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Sandoz’ application to market its generic human growth hormone Omnitrope may not meet the European Commission’s (EC) current regulatory pathway for follow-on biologics, according to an expert who adds the EC will likely approve the product anyway.
The biotechnology sector is lobbying the SEC to adopt recommendations to exempt smaller companies from financial reporting and auditing requirements, alleging these standards create burdens that will stunt innovation.
The European Medicines Agency (EMEA) has published five product-specific final industry guidelines for the development of biogenerics, including guidances for products containing insulin, somatropin and recombinant granulocyte-colony stimulating factor.
The European Medicines Agency (EMEA) is nearing a decision on whether to approve Sandoz’ generic biologic Omnitrope and Swiss firm BioPartners’ follow-on product Valtropin, experts familiar with the issue told WDL.
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 DID.
While Sandoz’ human growth hormone Omnitrope will likely be the first generic biologic to hit the European and U.S. markets, several other biologics also are poised to become follow-on products, says a new report.
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.
Drug development firm Alizyme’s experimental obesity drug cetilistat could challenge Roche’s obesity blockbuster Xenical for supremacy in the weight-loss treatment market that is expected to reach more than $2.5 billion by the end of the decade.
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.
Drug sponsors that use contract research organizations (CROs) can speed up the drug development process without compromising research quality, according to a new study that finds CROs are playing an increasingly larger role in drug development.