Biotechnology

Biosimilar drugs are proving more difficult to produce than originally anticipated in some cases. Merck & Co., Samsung and Teva Pharmaceutical Industries are among the companies that have recently faced delays in the development of biosimilars. Reasons for the setbacks include complications in creating biologics, new patents on the original drugs or their manufacturing processes, and unfinished US regulations for biosimilars. Thirteen biosimilar filings had been submitted to the FDA as of the middle of January. The cost of creating a biosimilar is estimated to be between $100 million and $300 million. Due to regulatory clarity and patent expirations, biosimilars have been sold in Europe for the past seven years. Novartis and Hospira are among the companies that are satisfied with their European biosimilar businesses.

Source: Wall Street Journal

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