The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Biologics

FDA Meeting on the Internet, Social Media and Online Drug Marketing

Following some perplexing moves by the FDA, including cracking down on Google search ads, the agency convened a two-day hearing on the use of the internet and social media for online drug marketing last week.  The goal of the hearings was to seek comments from

“all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry … [in order to] help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools.”

If you are interested in the topic, you can:

  1. Watch the whole thing via an archived webcast (until they take it down, but then you can read the transcript);
  2. Search #FDASM on Twitter and read the real-time reactions; or
  3. Read yesterday’s genius FiercePharma post by Tracy Staton that boils the whole thing down to a delicious executive-summary-type bite-size blurb. [See what I did there, FiercePharma headline writers?]

I highly recommend #3.

The FDA is collecting comments until February 28th (2010), after which it will digest the whole lot of them and formulate some guidance (likely) or regs (less likely) that will shape online behaviour.

P.S. Thanks LogoTwitter!

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Teva Decides Not to Wait for U.S. Biosimilars Legislation

In Beni’s post earlier this week on Biosimilars, he identified two major challenges to introducing follow-on biologics into the North American market: technical proficiency, and the absence of a regulatory regime.

Based on the approval of Teva’s biosimilar version of Neupogen in the EU last September, Teva has evidently cleared the first hurdle (and their joint venture with Lonza means their technical capabilities will only increase).

Yesterday, Teva announced that they were not waiting for a Biosimilars regime to be enacted before entering the U.S. market, and instead will take on the extra cost of filing a full BLA for their version of the biologic.

Does this mean we don’t need a biosimilars regime to get biosimilars to market?  Teva itself takes a different position.

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Trends in 2009: Facing the Challenges of Introducing Biosimilars or Follow-on Biologics in the North American Market

The so-called biotechnology drugs or biologics (large, complex protein molecules derived from living cells, usually by use of recombinant DNA technology) are among the fastest-growing class of pharmaceuticals. Within the next two years, some market forecasts predict that biopharmaceuticals will amount to more than 50% of newly approved medicines. In addition to a growing market share, a substantial number of major biotechnology-based drugs will come off patent and enable the development of new biologics. The race by pharmaceutical companies to get into biologics, or further support their existing biologics capacities in order to start developing biosimilars or follow-on biologics (FOBs), is illustrated by the rapid pace of recent deals in this sector. The latest of these deals is the acquisition of Insmed by Merck, which was announced last Thursday; however I believe this deal was more about expanding state-of-the-art manufacturing facilities rather than acquiring extremely valuable FOBs.

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