FDA approves first biosimilar

On Friday, the FDA announced its approval for the generic blood thinner Sanofi Aventis blood thinner Lovenox. This highly complex drug is the first and now sets a pathway for other generic copies of proteins to be approved. Due to the complexity of these molecules and how they are copied, there is still debate about how many safety trials should be conducted. (Source: The Great Beyond)

On Monday, Sanofi Aventis asked the US Court to withdraw it's approval on the drug, believing that they may have not tested for the same active ingredient in Levenox. They also stated in the papers they took to court:

"If not remedied, FDA's decision will cause Sanofi-Aventis irreparable harm and may result in entry into the market of a generic product that is not clinically equivalent to Lovenox with respect to safety or efficacy," Sanofi said in court papers.

Read more about Sanofi's request at Reuters.

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Sanofi Aventis eyeing Genzyme

Reports Friday surfaced that Sanofi Aventis is looking to acquire Genzyme as it faces stiff competition from generic drugs. By acquiring Genzyme, it would be their first step into the generics and biosimilars market.

According to the article:
[Genzyme's] research pipeline includes candidates for genetic diseases like Duchenne and Becker muscular dystrophy, Niemann-Pick type B, and Parkinson disease. It also has drugs in development for cardiometabolic, renal, transplant, and immune diseases, as well as hematologic oncology.

Source: Genetic Engineering & Biotechnology News

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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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Biorepositories Global Sample Management Survey

If you are in the Biorepositories field, we invite you to take our brief survey. Your feedback is extremely valuable to us as we plan for 2011. As a token of our appreciation IIR will offer you $300 off the current early bird registration price for Biorepositories 2010 if you register for the event and complete the survey before this Friday, July 23rd. Mention Priority Code XP1598LINKJULY.

Take the survey here:
http://www.surveymonkey.com/s/9FPV9DB

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The growing importance of biobanking

Jennifer Benner and Erik Koenig of BioProcess International recently wrote a piece focusing on the growing importance of biobanking. Much of this is due to the growing importance of well maintained samples that are growing due to the growing trend of personal health. Due to the growing rate, is it important that companies outsource this process? Read the full article here.

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Should biosimilars approvals require clinical trials?

A recent article at TheHill.com notes that there is no mandatory clinical trials for biosimilars. Could this have a direct impact on the ultimate safety and effectiveness of these new generic drugs? Just one impact could be the proper dosage associated in prescribing these drugs. What do you think? Could clinical trials benefit the effectiveness of biosimilars?

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Comination Products White Paper: Combination Products 2.0: Applying the New FDA Regulations

Med Gadget recently brought my attention to the white paper "Combination Products 2.0: Applying the New FDA Regulations." In this paper, Steven G. Richter, Ph.D., Microtest Labs, looks at how the FDA has struggled to keep up with the growing market, this paper reveals the insights to maintain good GMP practices and compliance. The white paper is free after completing a short form.

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Meet the 2010 Biorepositories Speaking Faculty

Now in its third year, the IIR Biorepositories event convenes the most innovative minds that have recognized early on the critical need to protect sample integrity. The expanded speaking faculty in 2010 is unparalleled - hear from these and other distinguished industry leaders on September 27-29, 2010 in Boston!

Helen M. Moore, PhD, Biospecimen Research Network, Office of the Director, NATIONAL CANCER INSTITUTE

Marie-Claire Peakman, Executive Director, PFIZER
Improve Biobank Effectiveness through Continuous Operational Improvement and Greater Customer Focus

Anita Nelson, Manager, R&D Human Sample Biorepository, GLAXOSMITHKLINE
Insights to Adapt Your Sample Management Strategy to the Changing Environment

Leonardo Sahelijo, MD, Medical Director, Pharmacogenomics, TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER

Click here for the agenda for more on these speakers and their sessions:
http://bit.ly/bZVxXS

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Early Bird Pricing Ends This Friday for the Combination Products Summit

Early Bird Pricing Ends This Friday, July 16th. This is your last chance to register and save $400!

Hear from these and other distinguished leaders at the Combination Products Regulatory & Compliance Summit on September 23-24 in Baltimore to answer your most pressing issues in the industry.

Speaking Faculty includes:
Angela C. Krueger, Regulatory Advisor, CDRH Product Jurisdictional Officer, Office of Device Evaluation, FDA
Understand and Anticipate Combination Product Activity at the FDA

John Kinzell, President & CEO, XERIS PHARMACEUTICALS
Understand and Anticipate Combination Product Activity at the FDA

Eric Edwards, Co-Founder & Chief Scientist, INTELLIJECT
Interpret Auto-Injector Guidance Ambiguities to Compliantly Adapt Best Practices

Michael Gross, Senior Consultant, BIOLOGIC CONSULTING GROUP
Minimize Enforcement Risk Through cGMP Compliance

Asif Sidiqui, Director, Regulatory Affairs, ROCHE MOLECULAR SYSTEMS
Learn What the FDA Looks for in Combination Product Clinical Trials to Avoid Early Life-Cycle Missteps

Suzanne Kiani, Senior Scientist, CMC Regulatory Affairs, GENENTECH
Minimize Enforcement Risk Through cGMP Compliance

View the complete agenda for all speakers and presentations here:
http://bit.ly/cqxdcP

Visit the webpage here:
http://bit.ly/d3J6Hk

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Who will be able to enter the biosimilars market?

A recent article at Reuters looks at the difficulty many could face entering the biosimilars market. Ludwig Burger states that he believes due to the difficulties of entering the market, it will be limited to a small circle of specialist companies. Currently, the only successful biosimiars manufactured are human growth hormones, but the next step will probably look towards therapeutic antibodies. Biosimilars, although generic versions of biologics, will only present the market with 20-30% discounts, but will see sales growth in terms of 2-3 times faster than the other generics on the market. Read the full article here.

So, now we want to hear from you. What do you think about the battle over biosimilars?

IIR’s 2nd Annual Business of Biosimilars conference delivers effective strategies to navigate scientific, regulatory, economic, and legal challenges you face to remain competitive in commercializing your biosimilar portfolio in the United States and abroad.

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Biobanking directory now online

SpecimenCentral.com is the online directory that pools all tissue banks, biobanks and biorepositories in one spot. This site hosts a directory containing over 230 biobanks across for continents.

SpecimenCentral.com features a dynamic bulletin board where researchers confidentially post a description of biospecimens needed for their research. Biobanks routinely check the board to learn about researchers’ needs. If there appears to be a match researchers are made aware of biobanks’ interest, or tender, and are free to reply. At a minimum, researchers stand to make qualitative and cost comparisons of tissue offers from multiple sources.

Source

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New biosimlars report looks at commercial aspect

Industry Standard News has a new report titled, "The Prescribing Outlook for Biosimilars." In creating this report, researchers talked to physicians about safety, efficacy, pricing and other critical characteristics when it came to prescribing these drugs.

According to Kevin Olson, President, ISR,
“Because there is no regulatory pathway for approval of these products in the United States, the body of writing on this topic focuses either on the development of biosimilars or on the implications for approval of the products after development. We believe that drug developers and their partners in commercial divisions should also understand what adoption of these products may look like as it may have implications for development strategy and will certainly impact a product’s commercialization strategy. For example, we found that over half of the respondents believe that regulatory authorities should require full-fledged clinical trials for biosimilars as a condition of approval. This was true among both U.S. prescribers and E.U. prescribers and is an indication of prescribers’ levels of comfort with the products.”

Read the full article and find out more about the report here.

IIR’s 2nd Annual Business of Biosimilars conference delivers effective strategies to navigate scientific, regulatory, economic, and legal challenges you face to remain competitive in commercializing your biosimilar portfolio in the United States and abroad.

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