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The European Medicines Agency (EMEA) could approve Sandoz’ generic biologic Omnitrope in April and Swiss firm BioPartners’ follow-on product Valtropin by May, experts familiar with the issue told Generic Line.
Two prominent lawmakers have urged the FDA to issue the guidance documents it has already drafted for follow-on insulin and human growth hormone (HGH) products.
An advisory committee for the European Medicines Agency (EMEA) has recommended the approval of Sandoz’ human growth hormone Omnitrope, a move the company hopes will lead to the launch of the first generic biologic in Europe.
The FDA is not approving some 505(b)(2) drug applications for products such as Sandoz's human growth hormone Omnitrope because the agency is concerned such a move would set a precedent for approving biological products under Section 351 of the Public Health Service (PHS) Act, according to one industry observer.
One potential problem with making follow-on biologics is that there isn't enough data to show how changes in manufacturing processes might affect a product's safety and efficacy, one expert said during a regulatory affairs conference in Baltimore.
Case law provides only inexact guidelines on just how much a protein sequence must vary in order to get around the patent on a biological therapy, according to a life sciences patent attorney.
The race to launch the first generic version of sanofi-aventis’ blockbuster blood thinner Lovenox is heating up, after Momenta Pharmaceuticals said it has figured out how to duplicate biologic drugs by characterizing complex sugars.
An abbreviated approval pathway for follow-on biologics in the U.S. is not expected until at least 2007, according to experts who note the European Union will have such a framework in place by November.
The FDA will likely release its guidance on developing follow-on biologics by late summer or early fall, FDA Commissioner Lester Crawford told House lawmakers recently.
The European Medicines Agency (EMEA) recently released draft guidelines outlining specific parameters for nonclinical and clinical studies for four biosimilar products — a move that brings the agency a step closer to forming a regulatory pathway for follow-on biologics.