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The Blog of Drug Discovery News

Looking for similars parity

So, I’m seeing talk of biosimilars showing up a bit more on the news feeds and in my e-mail inbox. Hard to say yet whether it’s a sign of a rising trend in pharma and biotech or whether it’s just a little jump in the frequency.

But I will say that in our January issue (heading out in the mail and also available online – key stories here and full issue in PDF form here), we had a sizable commentary about biosimilars. Given that the FDA is supposedly going to finally catch the U.S. up somewhat with its European peers in terms of an approval pathway and regulatory guidelines, I won’t be at all surprised to see a lot more stories on biosimilars like the one below that hit the newswires yesterday:

Merck & Co. and PAREXEL form strategic alliance focused on clinical development of biosimilar candidates

WHITEHOUSE STATION, N.J. & BOSTON—Merck & Co. Inc. and PAREXEL International Corp., a leading global biopharmaceutical services provider, today announced that they have entered into an alliance by which PAREXEL will provide strategic access to global clinical development services for designated biosimilar candidates to Merck BioVentures. Merck BioVentures, a division of Merck, is focused on the delivery of high quality biosimilars to the patients that need them.

“PAREXEL has extensive, industry-leading experience with biosimilar development, and we truly understand the scientific complexities, and regulatory pathways involved,” said Josef von Rickenbach, chairman and chief executive officer of PAREXEL. “We are committed to working with Merck BioVentures to assist in advancing its biosimilar portfolio in this rapidly developing market segment for the benefit of patients worldwide.”

Under the terms of the agreement, PAREXEL will provide Merck BioVentures with strategic access to a broad range of regulatory strategy and clinical development planning capabilities for the development of certain broad classes of biosimilars across various therapeutic areas, including exclusivity for certain candidates. The agreement also provides for the establishment of a dedicated Merck BioVentures unit within the PAREXEL organization. Further details of the agreement were not disclosed.

“Through this agreement, Merck BioVentures has secured broad strategic access to PAREXEL’s proven biosimilar clinical development experience,” said Michael Kamarck, president of Merck BioVentures. “This agreement positions Merck BioVentures for success with an industry leading partner that has the expertise and resources to conduct clinical development of our diverse portfolio of candidates to allow timely delivery of products to the marketplace.”

I think probably the biggest hangup for biosimilars (and thus news about any work on them) really has been the sluggish pace at which FDA seems to have been addressing this topic. I know that biosimilars pose many more challenges than do generic versions of some small-molecule drug or the like, but I can’t help but think that with European regulators already having trod this ground that the FDA has really been dropping the ball (as opposed to simply being wisely cautious).

Of course, that assumes that they agency even makes good on getting workable guidelines out this year. Lot of people and organizations fail at New Year’s resolutions.


January 13, 2011 - Posted by | Corporate, Government, Labwork & Science | , , ,

1 Comment »

  1. Well, it hasn’t even been hours yet since my post and I’m seeing other big news about biosimilars (also known as follow-on biologics).

    Bloomberg story titled Biogen Chief Sees Biosimilars as ‘Meaningful Revenue Stream’

    Wall Street Journal articles titled Biotech firms fight generics

    Comment by Jeffrey Bouley, ddn Managing Editor | January 13, 2011 | Reply

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