ASBM chairman Dr. Richard Dolinar was quoted in a PharmaTimes article covering the May 11 FDA hearing on biosimilars.
Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines, outlined five areas of concern that he said the FDA should resolve before they allow biosimilars onto the US market. These are: – the need for robust clinical testing; – the establishment of steps to monitor the global supply chain and manufacturing process; – the creation of track, trace and naming provisions; – the development of clear packaging, labelling and prescribing information; and – very close and deliberate scrutiny of a biosimilar before it is deemed interchangeable.
“We applaud the FDA’s efforts to bring biosimilars to the US market, but would urge a deliberate approach that is becoming of FDA’s critical role of ensuring the safety and efficacy of the nation’s drug supply,” Dr Doliar told the hearing.
No two biologics made from different cell lines or using different processes can be identical based on today’s science, and they are also highly sensitive to the manufacturing process, said Dr Dolinar. “In fact, altering a single manufacturing parameter can change a compound’s identity and/or the precise effect it has on the human body,” he added.