Merck taps Parexel to help it meet biosimilar ambitions
pharmafile | January 18, 2011 | News story | Research and Development |Â Â Merck & Co, Parexel, biosimilarsÂ
Merck & Co has enlisted the aid of contract research organisation Parexel to help it develop biosimilar versions of some of the leading biologic drugs which it hopes to have in late-stage clinical trials as early as next year.
The CRO has been given the task of helping Merck’s dedicated biosimilar business unit – Merck BioVentures – manage its portfolio of biosimilars, drugs which are close copies but not identical to off-patent biologic brands.
Merck made its first major foray into the biosimilar market back in 2009, with the purchase of a portfolio of candidates from Insmed in a $130 million deal.
The most advanced project in its pipeline are a biosimilar of Amgen’s Neupogen (filgrastim), an investigational recombinant granulocyte-colony stimulating factor (G-CSF) drug to prevent infections in cancer patients receiving chemotherapy. The firm is also developing a pegylated recombinant G-CSF designed to allow for less frequent dosing. Last year, it said it plans to have five biosimilars in late-stage clinical trials by 2012.
Under the terms of the agreement, Parexel will provide Merck BioVentures access to “a broad range of regulatory strategy and clinical development planning capabilities for the development of certain broad classes of biosimilars”, said Merck in a statement.
The strategic-level agreement will also see Parexel set up a dedicated Merck BioVentures unit within its own organisation.
Parexel “has the expertise and resources to conduct clinical development of our diverse portfolio of candidates to allow timely delivery of products to the marketplace,” commented Michael Kamarck, president of Merck BioVentures.
Biosimilars have already reached the market in Europe but to date none have been approved in the US. Last year however US regulator the FDA started a consultation process on the establishment of an approval pathway for biosimilars, also known as follow-on biologics.
The enactment of the Biologics Price Competition and Innovation Act of 2009 made it mandatory for the FDA to develop an abbreviated approval pathway for this type of drug. Many of these first-generation biologic agents have lost or are near losing patent protection, and without an approval pathway for ‘biogenerics’ prices have remained high.
Biologic drugs are made in living organisms can be highly variable in structural elements such as carbohydrate side chains, and this can have a dramatic impact on their activity in the body.
Manufacturing processes play a huge role in the three-dimensional structures of proteins and, because these are generally confidential, generic versions of biologics cannot be identical to their reference products. That means they need to be treated differently from a regulatory perspective compared to generics of small-molecule drugs.
Phil Taylor
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