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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Biosimilars Spotlight: Are Novel Names for Biosimilars Important?

Recently the Business of Biosimilars and Generic Drugs team sat down with Mark McCamish, the Global Head of Biopharmaceutical Development, Sandoz International, a Division of Novartis to discuss the current state of biosimilars and many of the regulations,or lack there of, facing the United States.

If biosimilars require the use of novel names, what could biosimilar companies do to try to turn that into a marketing advantage?

Mark's Answer:

I think there were misunderstandings early on when addressing the International Nonproprietary Name or INN. Novartis was very supportive from the beginning to use the same naming convention that is currently being used with all biologics in that they would have a unique proprietary name (for example the brand name). They would also use the INN or the generic name of the original molecule. When Novartis said that we wanted to use the same INN as the originator molecule (as would be done in all other conventions), we did not imply that we would brand our products with the INN or the generic name. We are global leaders in the commercialization of biosimilars and each one of our biosimilars has a unique brand name and then has the standard INN of the originator molecule. And that’s what we have been supportive of in the US. In reality, we do support a unique proprietary name, a unique brand name, but rely on using the same INN as the originator.

Some people have spoken on this and they’ve suggested the use of a unique INN different from the originator, which would be a little bit challenging from a track and trace and from a safety perspective because doctors and patients and payers really don’t know if they are getting the same product as the originator or not. We’ve been presenting this information in a straight forward fashion to convince FDA of the wisdom of using the same naming convention that they’ve used in all other biologics.

For access to the entire podcast and transcript, download it here.

The Business of Biosimilars and Generic Drugs Summit will take place September 10-12 in Boston, MA. For more information on the speakers and presentations for this year's event, download the brochure. if you'd like to join us, register today and mention code XP1786BLOG to save 25% off the standard rate!

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Rituxan Biosimilar Trials

With Rituxan's continued success and patent expiration approaching, many companies are counting the days until they can call this profitable drug their own. Rituxan's first noted success completely changed cancer treatment and today is used to treat chronic lymphocytic leukemia, non-Hodgkin's lymphoma, and rheumatoid arthritis.

 Sandoz, the generic subsidiary of Novartis (NVS), is conducting a phase 3 trial for its compound GP2013, a biosimilar version of Rituxan used to treat patients with follicular lymphoma. A phase 1 trial has also begun to test the drug's use in treating Rheumatoid Arthritis (RA). Sandoz claims that in the past few years it has developed a robust, high-yield and large-scale process for the production of biosimilar Rituxan at its facilities in Schaftenau, Austria.  They are the only manufacturer to have more than two biosimilars on the market.

With the recent development and trials underway which pharmaceutical companies do you think will be the first to act on this biosimilar?

The Business of Biosimilars and Generic Drugs Summit will take place September 10-12 in Boston, MA. For more information on the speakers and presentations for this year's event, download the brochure. if you'd like to join us, register today and mention code XP1786BLOG to save 25% off the standard rate!

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Happy Holidays from Future of Biopharma!

We're taking some time off from our coverage of biopharma to celebrate the season with our loved ones.  We want to sincerely thank you for your readership, your comments and your participation. We look forward to returning to the world of Pharma in 2012!  It has truly been the year of the biosimilar at the Future of Biopharma blog.

Here are our top posts from 2010:
A Future for Biosimilars and Biobetters
Large Pharma jumping head first in biosimilars
FDA approves first biosimilar
Podcast: Mark McCamish, Sandoz, on the approval of a generic version of Lovenox
Cell Based Assays: An Interveiw with Xu-Rong Jiang, MedImmune

We wish you Happy Holidays!
-Jennifer Pereira, Future of Biopharma Blog Manager

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FDA meets to discuss fee program for biosimilars

Last week, the FDA met with the Pharma industry to discuss the fee program for the pathway for biosimialrs, which is expected to be published soon.  These fees would go into place October 1, 2012, the Fiscal Year, and last through Fiscal Year 2017.


The four categories discussed during this meeting were:

• -Biosimilars Product Development Fees
• -Marketing Fees
• -Establishment Fees
• -Product Fees

In exchange for these fees, the FDA would create a series of goals to meet with both new biosimilars products and resubmitted biosimilars products in order to get them to the market.

They also shared that they  have set up a series of desired meetings to establish performance goals and procedures:

• - “Type 1” meetings with sponsors trying to revive stalled drug development programs;
• - “Type 2” meetings to discuss specific issues such as proposed study design or endpoints or questions where FDA will provide what it calls “targeted advice;”
• - “Type 3” in-depth data review and advice meetings; and
• - “Type 4” meetings to discuss the format and content of a biosimilar application or supplement.

According to Genetic Engineering and Biotechnology News, these objectives would be sent to Congress by January 15, 2012.

Do you think these fees and meetings will better help companies meet their goals they will have with biosimilars?

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Limited time offer to attend the 2nd Annual Business of Biosimilars

As a reader of Future of Biopharma, we'd like to extend to you a special offer. For five days only you will have the opportunity to save $700 off the standard registration rate at the 2nd Annual Business of Biosimilars Conference. This WEB ONLY offer is valid THROUGH MONDAY, JULY 26th. Please use code XP1586WEB to receive this discount. That's a Savings of $700 for a 3 day pass!

We know that this has been a tough year to get approval to attend events, but there's only ONE event your industry, key partners AND competitors will be at this year...Business of Biosimilars in September in Boston. In addition to saving $700 when you register through this offer, you will get access to a full day seminar on Strategies to Expedite Approval of Your Follow-On Biologic: From Drug Discovery to Post Approval, a dinner workshop on IP Protection and Patent Litigation, and over 30 expert faculty members including representatives from Sandoz, Biogen IDEC Inc., Hospira, Sanofi-Aventis, the FTC and much more.

Visit the webpage here to find out more information on the speakers and topics of this event:
http://bit.ly/cA9IaI

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Cipla buys stake in biosimilars market

According to FierceBiopharma, Indian drug company Cipla has purchased major stakes in Asian biotechs that have biosimilars in the pipeline. Their main goal is to create biosimilars of current biologics that are extremely expensive, Roche's Avastin, Herceptin and Enbrel. Read the full article here.

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