The impact of an FDA warning letter issued last month for a Celltrion plant in South Korea has broadened to Teva Pharmaceuticals.

South Korea’s Samsung BioLogics reported a 56% jump in sales to $420 million (KRW 459.8 billion) for 2017, which the company attributes to boosts from two of…

The FDA has issued a warning letter for the Celltrion plant in South Korea that makes Pfizer's Remicade biosimilar, Inflectra.

An API maker in Bizen, Japan, has joined a growing list of Japanese drugmakers to be criticized by the FDA in warning letters and bans.

U.S biotech Evolus alerted investors that FDA concerns with a Daewoong plant in South Korea that will make its Botox copy could delay its approval.

China’s Clover Biopharmaceuticals expects to have a biologics facility completed by year-end where it will produce its Enbrel biosimilar candidate.

An Indian company that has had its drugs banned by the FDA has bought a contract manufacturing operation in the U.S.

Celltrion Chairman Seo Jeong-jin has confirmed that the South Korean drugmaker has decided to build its third plant outside of South Korea.

The EMA has decided to block the API for amoxicillin trihydrate produced by a company in China whose manufacturing oversight has been lacking.