By Donald Zuhn --
Innovators Looking for Help from Follow-on Biologics
Last week, Merck announced that it had acquired Insmed's portfolio of follow-on biologic therapeutic candidates as well as its biologics manufacturing facilities in Boulder, CO (see "Biotech/Pharma Business Briefs"). While the timing and target of the acquisition may have been somewhat surprising, Merck's move into follow-on biologics was not, as the company revealed plans to do so back in December (see Reuters report).
With respect to the acquisition's timing, Merck's purchase of Insmed's follow-on biologics technology comes less than ten weeks after Merck announced the creation of Merck BioVentures, a new division of the company charged with the development of biologics and follow-on biologics (at the time of that announcement, Merck indicated that it would have at least five follow-on biologics in late-stage development by 2012). And with respect to the target, Insmed had, over the past twelve months, moved to the forefront of the U.S. follow-on biologics movement by launching a national awareness campaign last February to promote the establishment of a follow-on biologics regulatory pathway in the U.S., and then in July, demonstrating that its recombinant human granulocyte colony stimulating factor (G-CSF) follow-on biologic was bioequivalent to Amgen's FDA-approved Neupogen®. Merck's purchase of Insmed appears to be due, at least in part, to the looming "patent cliff" -- i.e., the expiration of key pharma patents between 2009 and 2011 -- that is confronting many innovators, as well as the timeline for Merck's own follow-on biologics pipeline.
Merck is not alone among innovator drug companies looking to get involved in follow-on biologics, as Eli Lilly and Co. and Astrazeneca have also expressed a recent interest in biosmiliars. Two days after Merck's announcement, Lilly stated that the company was "very much considering" a push into follow-on biologics (see Reuters report). According to Reuters, Lilly Research Laboratories President Steven Paul contended that follow-on biologics would be "a very reasonable thing for Lilly to do, probably down the road."
Less than two weeks after Lilly expressed a desire to get into follow-on biologics, AstraZeneca made a similar announcement (see Financial Times report). As with Lilly, which purchased biologic drug developer ImClone Systems last fall, AstraZeneca believes a move into biosmiliars will build upon the company's existing biologic drug operations. According to the Financial Times, AstraZeneca's interest in biosimiliars also appears to be related to the patent cliff, with the company unable to balance current products coming off patent with new drugs from its pipeline.
Amgen Preparing for More Generic Competition
Amgen CEO Kevin Sharer told attendees at last month's JP Morgan Global Healthcare Conference, that the biotech company was preparing for generic competition in Europe with respect to its drug Neupogen® (see Reuters report). Some of that competition will likely come from Merck BioVentures, now that Merck has acquired a biosimiliar portfolio that includes recombinant G-CSF. In addition, Teva received approval for its own G-CSF product last September (see "Teva Receives EU Marketing Authorization for G-CSF Biosimilar").
Despite the competition, however, Amgen's CEO stated that the company could "hold very significant market share at attractive revenues for a long time post patent expiry." His statement is supported by Amgen's recent experience dealing with generic competition in Europe for its anemia drug Epogen. With respect to that drug, Mr. Sharer noted that the company had "felt the effects of a biosimilar, but did substantially better than expected."
Novartis Gets EU Approval for Filgrastim
Amgen will also be facing generic competition from Novartis, as that company's generic division, Sandoz, announced that it had received approval from the European Commission (EC) for its filgrastim (i.e., G-CSF analog) biogeneric. Last November, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion for the Sandoz drug Zarzio (filigrastim) for the treatment of neutropenia. The EC's decision came as no surprise, as the EC usually follows the CHMP's recommendations. Zarzio was approved for use in treating the same indications as Amgen's Neupogen®.
For additional information regarding this and other related topics, please see:
• "Biotech/Pharma Business Briefs," February 13, 2009
• "Teva Receives EU Marketing Authorization for G-CSF Biosimilar," September 24, 2008
• "Insmed Announces Bioequivalent G-CSF Biologic," July 10, 2008
• "Insmed Announces National Awareness Campaign Regarding Follow-on Biologics," February 13, 2008