Regulators at the European Medicines Agency have issued a positive opinion for a generic biotech product, laying the stage for what may become the first approval for a generic biotech treatment. The move is being closely watched in the global biotech industry. U.S. biotech companies have fought for years against any move to permit generic biotech drugs, saying that the manufacturing process is too complex to permit knockoffs. But Europe has been moving steadily toward a new regime that will green-flag so-called biosimilars, which may well put pressure on the FDA to follow suit.
"The positive CHMP opinion for Omnitrope is an important step on the way to make this medicine available for patients who need it," said Dr. Andreas Rummelt, CEO Sandoz. "Omnitrope will contribute to cost savings in the healthcare systems and we are confident that the European Commission will now grant marketing authorization."
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