Politics might not be the only obstacle in getting biosimilars approved in the US, though much of the rest of the world seems intent on obtaining approvals as fast as possible, according to a new report from research company Frost & Sullivan.
Johnson & Johnson (J&J) has called on the US FDA to prevent biosimilars being given the same non-proprietary names as their original biologics, while the European Generics Association maintains the practice is “proven to be safe” and “supported...
Novartis has joined the debate regarding the international nonproprietary names (INNs) of biologics saying some companies are casting unnecessary doubt on biosimilars under a guise of pharmacovigilance.
With in-house production and manufacturing capacity, as well as a deal with Merck Serono, India-based generics giant Dr. Reddy’s is looking to bring as many as four biosimilars to the EU market by 2019.
Highly sought-after guidance on quality agreements for contract manufacturing organizations (CMOs) and biosimilar developers is expected in 2013, according to a list of future guidance documents released by the US Food and Drug Administration (FDA).