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Boehringer Ingelheim announced that BI 695501, its adalimumab biosimilar candidate to Humira®*, has been accepted for regulatory review by the European Medicines Agency (EMA) and the U.S Food and Drug Administration (FDA).
Boehringer Ingelheim announced today that BI 695501, its adalimumab biosimilar candidate to Humira®*, has been accepted for regulatory review by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
The US Supreme Court on Friday agreed to hear Novartis' appeal seeking to overturn a law that requires companies to wait 180 days after obtaining FDA approval for a biosimilar drug before they can begin marketing the product.