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International prescribing incentives for biosimilars Reports | Posted 07/12/2018

In October 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) published a report that investigated, among other subjects, international prescribing incentives for biosimilars [1].

FDA approves first rituximab biosimilar Truxima Biosimilars/News | Posted 07/12/2018

On 28 November 2018, the US Food and Drug Administration (FDA) approved its first rituximab biosimilar, Truxima (rituximab-abbs), the first biosimilar for the treatment non-Hodgkin’s lymphoma (NHL).

FDA issues post-CRL meeting guidance for generics makers Guidelines | Posted 07/12/2018

In December 2018, the US Food and Drug Administration (FDA) published a new guidance document to assist generics makers with meetings with the agency following the issuance of a complete response l...

Boehringer Ingelheim and Sandoz abandon biosimilars Biosimilars/General | Posted 07/12/2018

Boehringer Ingelheim has decided to abandon biosimilars outside the US. While Sandoz has decided not to pursue biosimilar rituximab in the US.

Positive results for Chinese rituximab and trastuzumab copy biologicals Biosimilars/Research | Posted 07/12/2018

Researchers from Shanghai Henlius Biotech have presented positive phase III study results for their rituximab [1] and trastuzumab [2] copy biologicals.

Way cleared in US for Suboxone and Zytiga generics Generics/General | Posted 07/12/2018

The US Court of Appeals is clearing the way for generics competitors to enter the market. The court has lifted an injunction on Dr Reddy’s Suboxone (buprenorphine/naloxone) generic and upheld a dec...

Positive phase I results for Fresenius Kabi’s pegfilgrastim biosimilar Biosimilars/Research | Posted 07/12/2018

Fresenius Kabi, one of the independently operated business segments of global healthcare group Fresenius, announced on 9 October 2018 that results from two phase I studies of its pegfilgrastim bios...

Glenmark gains FDA approval for MS and pneumonia generics Generics/News | Posted 07/12/2018

In November 2018, Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced the approval of generics for the treatment of multiple sclerosis (MS) and pneumonia.