Adapting to New Biosimilar Regulations and Advancing Success

Today's guest post features highlights from the first day of the Business of Biosimilars and Generic Drugs Summit and is authored by Amy M. Belton, PhD, Research Associate, Johns Hopkins University School of Medicine.  The recap for Day 1 of Business of Biosimilars and Generic Drugs is here.

A presentation by Ms. Suzanne Sensabaugh, CEO Hartman Willner, LLC covered the FDA’s current definitions of comparable, equivalent, and interchangeable with respect to biosimilars. Under section 351k and 351a pathways exists for approval of a biosimilar, highly similar interchangeables and biobetters. Where an interchangeable must be shown to have the same clinical effects if switched with the innovator. The biobetter pathway 351a is different in many ways from that of the biosimilar 351k pathway. A therapy seeking biobetter designation cannot be labeled as a biosimilar or an interchangeable. The biobetters use placebo or standard of care for either superiority or non-inferiority studies. In addition, reference products approved outside of the US can be used as a standard if analytical testing shows similarity. The 351a process for biobetter development also requires manufacturers to conduct clinical studies for all indications, and toxicology and pharmacology testing (can be reduced testing options per FDA), and clinical trials (data can be included on the label). As for payments, the user fees for biobettrs are due at BLA filing, where biosimilar user fees are due at the pre-IND meeting. Because of the increased stringency in biobetter development this usually takes 15 years to gain approval compared to the 7 years for biosimilars.

Steven Lucio, Director Pharmacy Clinical Solutions, Novation a healthcare supply chain organization offered insights into the product awareness and acceptance of generic drugs and what biosimilars will need to consider when battling this hurdle in getting acceptance of biosimilars from doctors, pharmacies, and the general public. He showed data of how generics approvals have resulted in a steady decrease in annual drug expenditures from 1998-2011. However, he also showed how these approvals have also contributed to the national drug shortages since the inception of generic drugs from 2001-2012. He also outlined the generally acceptability and ease of uptake of generic drugs where in most cases interchangeability is a nonissue, except in cases of highly sensitive clinical populations. An example, was used in therapies for mood stabilizers, anticoagulants, hormones, bronchidilators, antiepileptic drugs, and antiarrythmics. These therapeutic areas often have patient populations that are elderly, women, pediatric, immunocompromised, or have acute coronary syndromes. As for the biosimilars market it is imperative that manufacturers develop a greater recognition of best practices and adopt these practices during product development , manufacturing, and regulatory approvals. In addition, increased publications discussing biosimilars provide an easier clinic to pharmacy acceptance.

Novation is actively engaging in activities to provide biosimilar support strategies by way of publishing two white papers, speaking engagements, drug monographs, cross reference charts, pricing forecasts, and therapeutics class reviews of therapies in the pipeline which provides information on therapies in the pipeline.

The final presentation for the conference was by Hans Sauer, Associate Counsel for IP, BIO and Bruce Leicher, Senior VP and /general Counsel, Momenta. The mainly discussed the patent exchange process and what biosimilar developers need to keep in mind during this short and many times stressful time. They mentioned many of the same pitfalls discussed by Mark Hyman, of Human Genome Sciences and others regarding preparing a litigation strategy long before the new drug application is submitted to the FDA and the innovator company. There were also discussions as to whther the term “shall” does actually compel a biosimilar developer to disclose its NDA to the innovator company for review of patent infringement. However, this would leave the biosimilar company open for litigation and at a possible disadvantage in the judiciary depending on the judges interpretation of the statute.

In addition to the presentations at this years meeting there were also demonstrations of novel devices that can be partnered with biosimilars to offer added advantages to delivery of therapies. One such example, is the DosePro system from Zogenix which is a commercially available prefilled disposable needle free drug delivery system for subcutaneous injection. A brief demonstration was done by John Turanin, VP and General Manager, Zogenix to show its ease of use and potential for use in the biosimilar development. Additional information regarding the DosePro Technology and the company Zogeneix can be found by clicking the following link: http://www.zogenix.com/

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Business of Biosimialrs Day 2: Celltrion, G. Steven Burrill and more

Today's guest post features highlights from the first day of the Business of Biosimilars and Generic Drugs Summit and is authored by Amy M. Belton, PhD, Research Associate, Johns Hopkins University School of Medicine.  The recap for Day 1 of Business of Biosimilars and Generic Drugs is here.

The 13^th Annual Business of Biosimilars and Generic Drugs meeting officially opened today with a presentation from the session chair Carrie Burke, Director of Alliance Development, Shire. Carrie gave an overview of the healthcare market with a description of the cost pressures associated with biosimilar development. She was also able to assure the audience that given the current US political climate, it is unlikely that the Biologics Price Competition and Innovation Act (BPCIA) would be affected. She also gave an overview of the BPCIA She also gave a brief overview of the recent draft guidances released by the FDA and offered clarifications for much of the language in the draft guidances released by the FDA earlier this year.

Mr. G. Steven Burrill, CEO Burrill and Company gave an overview of how technology is influencing the future of modern medicine, suggesting that within the next 5-10 years digital healthcare will revolutionize medicine. He discussed many of the modern ideas of digital healthcare and placing a patients healthcare in the palm of their hands. An example, is the AliveCor ECG app for iPhone which is a wireless, clinical quality cardiac event recorder that allows users to monitor heart function in real time. This information can be stored and uploaded for later use. He also described a new business model “co-opetition” or “cooperative competition” in which companies that were traditionally rivals partner in order to reach a competitive advantage. This can be seen in many of the partnerships forming between multinational drug manufacturers and generic companies. He also discussed the need to accept that emerging markets are here to stay but that big Pharma is not giving up without a fight. Mr. Burrills presentation offered a broad forecast into the future of the biotherapeutics space while keeping in mind that the power to determine the success of a biosimilar lies in the payer and not the regulatory hurdles required for approvals.

A portion of the business focus of Xencor is the development of superior biotherapeutics, which they refer to as biosuperiors. Xencors proprietary Xtend™ Technology, which is used to develop biosuperiors of old antibodies, was described by John Kuch, VP Finance, Xencor. The biosuperiors are apart of Xencors proprietary candidates pipeline having a modified Fc region by changing two amino acids. Various biosuperiors have been designed to have an increased in vivo half-life that can result in new dosage routes, increased patient convenience and reduced cost. These changes result in a biosimilar molecule whose dose and frequency can be modified to make the biosimilar more attractive to payers. One key aspect of Xencors technology is that biosimilar manufacturers can effectively integrate a key differentiator between a competitors biosimilar and their own. The biosimilar technologies developed using Xencors, Xtend™ Technology, could also result in a biosimilar developer receiving approval as a new therapy with increased efficacy, lower cost and more convenience for the patient. The Xtend™ Technology was an example of the types of advantages that biosimilar manufacturers have to incorporate into their biosimilar technologies. Simply developing, testing, and manufacturing a biosimilar is not enough to be a winner in this market. Manufacturers will also have to incorporate the better, faster, cheaper model to biosimilar development. As evidenced by the history of the generics market, being just as good as the innovator is not enough to be competitive. Biosimilar manufacturers will have to incorporate key differentiators into the development of biosimilar therapies in order to truly be competitive.

Several of Xencors proprietary biosuperiors for autoimmune and cancer targets are currently available for licensing.  Visit Xencors webpage.

One of the most anticipated talks for this meeting was given by Dr, ShinJae Chang, VP of R&D, Celltrion in reference to Celltrions biosimilar Remsima which was recently approved by the Korean FDA and is now under review by the EMA. During his presentation Dr. Chang gave a detailed profile description of Celltrion and its capacities in developing biotherapeutics. Celltrion has been in business since 2002 and is currently the largest company on the KOSDAQ (equivalent to US NASDAQ). Remsima is the world’s first biosimilar monoclonal antibody developed using internationally recognized regulatory standards. Remsima is a biosimilar of Janssen Biotech’s blockbuster biologic Remicade which reportedly had global sales of nearly $9 billion dollars in 2011 alone. Given the decreased manufacturing costs Celltrion offered a detailed overview of the comparability data first presented at the European League Against /Rheumatism in Berlin, Germany back in June 2012. Since then, Celltrion has not only received KFDA approval for Remsima but has also submitted an application to the EMA for approval in Europe which they expect to hear the results later this year. Dr. Chang shared much of the impressive quality comparability data for the Remsima biosimilar when compared to the innovator Remicade and the clinical trial strategy. We were also shown Celltrions global marketing strategy for biosimilars which includes partnerships with companies such as Hospira. As a result of its success and the potential global demand for Remsima, Celltrion has plans to increase its workforce by almost 13% by the end of 2012. In addition, they are working on their product pipeline which includes eight biosimilar monoclonal antibody therapies and five novel drug candidates in its R&D division. The future for Celltrion appears bright as they were the first to reach the finish line in developing biosimilars.

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Celltrion Gains Approval for Remicade Biosimilar

Today's guest post is authored by Amy M. Belton, PhD, Research Associate, Johns Hopkins University School of Medicine.

A leading Korean biopharmaceutical company, Celltrion, recently announced their successful approval by the Korean Food and Drug Administration (KFDA) to develop the biosimilar monoclonal antibody Remsima.  The biosimilar “Remsima” is a version of the blockbuster drug Remicade (inflixamab) by Johnson and Johnson.  Remsima was approved under the global biosimilars guidelines making it the world first true biosimilar antibody.  Remsima has been approved by the KFDA for the treatment of rheumatoid arthritis, ulcerative colitis (UC), Crohn’s disease, ankylosing spondylitis and psoriasis.

The cost of treatment with Remicade can range from $19000-$22000 a year per patient. These costs are usually covered by major medical insurance. The biosimilar Remsima could offer a 20-40% decrease in cost for the payor and patient. This offers significant decreases in the costs associated with treatment. Celltrion started as a contract manufacturing organization and is now entering into agreements with companies such as Hospira to develop biosimilars for other blockbuster drugs.

At next month's 13^th Annual Biosimilars and Generic Drugs meeting in Boston, MA participants will be able to get insight from ShinJae Chang, VP, R&D Celltrion into the strategies used to develop and market biosimilars globally.  For more on this session, download the agenda.  If you'd like to join me in Boston, register today and mention code XP1786BLOG to save 15% off the standard rate!

Do you think Celltrion will be able to successfully market Remsima globally (US, EU markets)? If not, what do you think will be some of their roadblocks? Do you think they are now the global leader in biosimilar development?

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India unveils Draft of Biosimilar Guidelines

The government of India made a surprising announcement during the Biotechnology Industry Organization (BIO) international meeting June 18-21, 2012 in Boston MA.  BIO is the annual meeting of biotechnology leaders from across the globe.  With the Supreme Court upholding the Affordable Care Act (ACA) of 2010 just days after the convention it was appropriate that India unveil its guidelines for biosimilar development at BIO 2012. The ACA included the Biologics Price Competition and Innovation Act that allow the development of biosimilars.

The guidance document released by India is entitled “Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India” and outlines the biosimilar development procedures for Indian biopharma and global players. Here is a link to the guidance documents. India is now open for business in terms of international development and commercialization of biosimilars. The guidelines allow for India to be a part of the regulated global market currently developing biosimilars. Many hope that when the US FDA finalizes the guidances for biosimilars the market will begin to grow and develop. These guidances also assure global biopharma companies that India is developing standards similar to those already established in biotherapeutic development.

What are your opinions of the guidelines as the have been released?  How do you think these guidelines will affect global biopharma development?  Do you think India will be view as potential partners or competitors to the more established biotherapeutic markets?

For more information on this topic, check out the presentation by ShinJae Chang, VP, R&D, Celltrio titled "The Strategy and Case Study of Global Biosimilar Development" at the 13^th Annual Business of Biosimilars and Generic Drugs.  For more information on this session and the rest of the program, download the brochure.  If you'd like to join us in Boston for the event, register today and mention code XP1786BLOG to save 25% off the standard rate!

Do you see reglation of biosimilars coming soon to the US market? Why or why not?

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Business of Biosimilars & Generic Drugs Session Spotlight: Outlook and Strategic Impact of U.S. Biosimilar Approval Pathway

After years of waiting, the FDA has finally released its draft guidelines for the development and approval of biosimilars. Now that the industry has a clear path forward, it is essential that you capitalize on the expert commentary of our speakers from Pfizer and Shire in order to best understand how to remain in compliance and reliably push your biosimilar candidates to the market.

Brian Harvey, Pfizer

This September at Business of Biosimilars and Generic Drugs, Brian Harvey, Vice President, U.S. Regulatory Strategy, Pfizer and Carrie Burke, Director of Government Affairs, Shire will be on hand to examine this topic in their presentation "Outlook and Strategic Impact of U.S. BiosimilarApproval Pathway" on Wednesday, September 12.  For more on this presentation and this year's event, download the brochure. If you'd  like to join us in Boston, register and mention code XP1786BLOG to save 25% off the standard rate.

Featured Session: Outlook and Strategic Impact of U.S. Biosimilar Approval Pathway
Featured Speakers: Brian Harvey, Vice President, U.S. Regulatory Strategy, Pfizer
Carrie Burke, Director of Government Affairs, Shire
About the Session: This timely session will focus on the latest updates on the
FDA’s user fee structures for biosimilars as well as their 2012 draft guidelines. The most signifi cant aspects of the biosimilar guidelines will be the allowability of foreign referent products, the assignment of unique non-proprietary names, and the extrapolation of multiple indications through shared MOA. The follow-on industry has its strong opinions on all three of these.

• • Grasp how the new legislation helps you overcome the barriers to market entry
• • Reassess your application and patent defense methods in light of the FDA’s “wall” around innovator data
• • Structure your analytical teams around the comparability methods that regulatory reviewers prefer
• • Frontload your capacity for factor certifi cation, PK studies, and other means to equate point of origin and/or functionality to regulators
• • Overcome additional roadblocks to biosimilar interchangeability at the state level
• • Strategize methods for turning unique name requirements into competitive advantage
• • Protect your budgets from any new studies that may be required if extrapolation of indications is not allowed

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Which companies will be at the 3rd Annual Business of Biosimilars & Biobetters Event?

The 3rd Annual Business of Biosimilars & Biobetters event is taking place this month! Register now before it’s too late and join these industry leaders:

AET * Amgen Inc * Arecor Ltd * Biogen Idec * Boehringer Ingelheim Pharmaceutical * Bristol Myers Squibb * Celestial Biologicals * Celltrion Inc * Center for Medicine in the Public Interest * CEVEC Pharmaceuticals GmbH * Decision Resources * Dr Swamys Lab * Eden Biodesign Inc * EMD Millipore * Engel & Novitt * Express Scripts Inc * Fish & Richardson * Fuld & Company * Greenblum & Bernstein PLC * Hospira Australia * Johnson & Johnson * KBI Biopharma * Ken Pang * Makovsky & Co Inc * Merck & Co Inc * Momenta Pharmaceuticals Inc * Montclair Bioequivalence Services LLC * MPM Capital * NIST National Institiute of Standards and Technology * Novartis Pharmaceuticals * Panacea Pharmaceuticals * Percivia LLC * Pfizer * PPD Inc * Quintiles * Ropes & Gray LLP * Sandoz Inc * Sanofi Aventis * Schiff Hardin LLP * Smithers Group * SpringLeaf Therapeutics Inc * STC Biologics Inc * Synthon Pharmaceuticals Inc * Technology Catalysts Corporation * Teva Neuroscience * The Texas A&M University System * Valin Technologies * Vital HealthPoint *
Wolters Kluwer

IIR's 3rd Annual Business of Biosimilars & Biobetters, taking place September 19-21 in Boston, is designed to help you develop effective strategies to navigate scientific, regulatory, economic and legal challenges to remain competitive in commercializing your biosimilar portfolio in the United States and abroad.

For more information on the speakers and the presentation at the event, download the brochure here.

As a reader of the Future of Biopharma blog, if you register before September 9 using code XP1686BLOG, you'll receive 1 complimentary workshop of your choice! If you have any questions about the event, please feel free to contact Jennifer Pereira at jpereira@iirusa.com.

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FDA realigns to support possible biosimilars change

Image Source: FDA

On August 15, the generics industry stuck a deal with the FDA that could expedite the approval process of generic drugs after fees are paid.  It is believed that first year fees could reach up to $299 million to speed up the review process which typically takes 2 1/2 years currently for approval.

The FDA Office of Generic Drugs has reported they are adding a second Division of Bioequivilance and a fourth Division of Chemistry.  Director Helen Winkle released the plans in a memo from the Office of Pharmaceutical Science.  According to Cutting Edge Information, they believe that the addition of a second Division of Bioequivilence could indicate that there has been an agreement reached after the initial Biologics Price Competition and Innovation Act passed Congress in 2009.

The Business of Biosimilars and Biobetters Conference will be addressing the abbreviated pathway  head on, with a panel of experts examining the pros and cons of paying for expediting the process of the approval of generics.

How do you feel about paying to expedite the review process?

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Requests for no discussion of biosimilars in the Trans-Pacific Partnership meeting

The House Democrats have written President Obama a letter that encourages him to leave all biosimilars discussions out any discussions that will take place.If the discussions were to take place it would conflict with the Fiscal Year 2012 budget proposal.

The Pharma Times stated:
The TTP is a multilateral free trade agreement which the US is currently negotiating with Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore and Vietnam. If the finally-agreed version deal were to include 12 years' exclusivity for biologics, this "would impede the ability of Congress to achieve the Administration's proposed seven-year change without running afoul of US trade obligations," the Democrats warn the President, adding: "we see no reason for the United States to agree to such a provision, much less to propose it."


This September at Business of Biosimilars and Biobetters, representatives from Momenta Pharmaceuticals, Inc., Schiff Hardin LLP and Fish & Richardson will be conducting the workshop Biosimilar IP Protection and Patent Litigation Strategies for Development in the US and Abroad which will examine regulatory and legal affairs, legal counsel and IP/Patent litigation within biosimilar and originator biopharmaceutical and biotech companies. For more information, download the brochure.


Do you believe it is best for Obama to leave biosimilars out of these discussions?  Why or why not?

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Biosimilars FDA Approval won't be "One Size Fits All"

As the FDA comes closer to releasing guidance on biosimilars, they've found that a "One Size Fits All" guidance won't work in this case.  They will find a way so that the evidence of the performance of the drug is weighted in order to assess whether or not the drug is safe for the market.  With the huge market that is sure to come from these drugs as soon as they are approved for use in the United States, expected to be a compound annual growth rate of 89.1% from 2009-2014 in the United States, many producers are waiting on ruling from the FDA.  Mass High Tech even goes as far as to say that that Americans will dominate the market by the end of that time frame in 2014.

There is one important part to the approval.  The law firm Ropes & Gray of Boston believes under the totality of evidence approach, animal and clinical studies will be required for the foreseeable future for approval of protein biosimilars, but the scope and extent of such studies may be reduced where detailed fingerprint-like characterization is used.  Much of this is due to the fact that the biosimilars aren't exact genetic copies of the drugs.

Suzanne Sensabaugh, MS, MBA, Founder and Member, HartmannWillner LLC will be joining Business of Biosimilars and Biobetters to look at the regulatory update for biosimilars. The event will take place September 19-21, 2011, in Boston, MA as a part of the Clinical Business Expo. For more information on the event and it speakers, download the brochure here.


Do you agree?  Should biosimlars approval be weighted on the findings from the manufacturer on a case by case basis?

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India's biosimilars growth expected to grow exponentially

Biosimilars market share is expected to grow exponentially over the next few years at a rate of 52% between 2010 and 2015.  Two of the factors leading to this are patent expirations on biologics and the rising cost of drugs. India is also a leader in biosimilars production, with 40 of the biologics marketed in India, 25 of the biologics are manufactured there.  They've also embraced the manufacturing of the drugs due to the cost advantage of development, which reduces the appeal of importing them.  Learn more about the stats above in the Global Biosimilars Market Analysis, which was recently released.

At the Business of Biosimilars and Biobetters Conference taking place September 19-21, 2011 in Boston, MA, Subir Basak, PhD, MBA, Chief Executive Officer, Celestial Biologicals, Chief Commercial Officer, Intas Biopharmaceuticals, will examine how the biosimilars market is expected to evolve in India and the IP and tax implications of their future development.  For more information on this presentation and the others at the Business of Biosimilars and Biobetters Conference, download the brochure here.

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Should biosimilars be required to go through clinical trials?

Biosimilars, while created to lower the cost of biologics, are not exact replicas of their original drugs they were created after. Due to their biological composition, side affects and treatments could be different, unlike the generics created for chemical drugs. This is exactly why the National Hemophilia Foundation is asking that clinical trials be a part of the approval process when clotting factors are involved.  Concerns from this community include the possibility of an infectious pathogen contaminating the cells or culture medium the biosimilars are produced in and potential immunogenicity, the ability to trigger an immune response. For those who have bleeding disorders, it is a great concern to change their medication, because the outcome is not known, and changing inhibitors and possible neutralization that could occur.  Hemaware reports that the patient population is clearly skeptical of potential biosimilars that will come out to treat their conditions.

At the Business of Biosimilars and Biobetters Conference during the full day symposium, there will be a discussion about the need of clinical trials between experts in the field.  To find out more about this session and the full program, download the brochure.  Business of Biosimilars and Biobetters will be taking place September 19-21, 2011, in Boston, MA; as a part of the Clinical Business Expo.

What do you think?  Should biosimilars be required to go through clinical trials before they are brought to market?  Or is there a need to have priorities on which biosimilars should go through clinical trials?

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The 3rd Annual Business of Biosimilars & Biobetters final agenda is now available for download!

Business of Biosimilars and Biobetters is the three day event has expanded to order to better address the needs of our audience and reflect the changes in the biopharmaceutical industry, including global biosimilar and biobetter commercialization opportunities with in-depth analysis of scientific and business development considerations.

The agenda is now available for download here.

New for 2011, this event allows you to focus on what matters most:

• • Identify strategies and tools to prepare you for what you need to ensure profitability for your biosimilars and biobetters through two customized tracks focused on development and commercialization
• • Collaborate with your peers and discuss current hot topics and industry trends through specialized roundtable discussions
• • Overcome scientific challenges and streamline biosimilar development using lessons learned from the expanded full day scientific symposium
• • Gain insight into biosimilar and biobetter opportunities around the world with regional spotlights on Asia, the EU and the US
• • Network with 200+ leading experts, 600+ participants and 50+ exhibitors across the clinical development continuum in the brand new Clinical Business Expo exhibit hall

As a member of the reader of the Future of Biopharma blog, if you register before May 31st using code XP1686BLOG, you'll receive $600 off the standard rate!

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