Samsung Bioepis - a collaboration between Samsung Biologics and Biogen - has already achieved regulatory success for its SB4 etanercept product in Korea, Europe and Australia, and today adds Canada where Brenzys has been approved for the treatment of rheumatoid arthritis and ankylosing spondylitis.
The product becomes the first version of Amgen’s Enbrel to be approved in Canada and comes less than two weeks after the US approved its first etanercept copy, Erelzi, made by Novartis subsidiary Sandoz.
According to a Samsung Bioepis spokesperson, a Biologics License Application (BLA) has not yet been submitted to the US Food and Drug Administration (FDA).
However, we were told at the time that Sandoz’s approval was a “milestone” and “a positive step forward for the biosimilar industry, and, most importantly, for autoimmune patients across the United States.”
In Europe, etanercept is known as Benepali and is marketed by Biogen. Brenzys will be launched by Merck & Co. under terms of a commercialisation agreement which sees the Big Pharma firm hold marketing authority for the SB4 molecule outside of Europe and Japan.
Invalidated Humira patent
In further good news for Samsung Bioepis, the firm has been successful in invalidating one of AbbVie’s indication patent, KR 1,283,877, for Humira (adalimumab) in Korea.
The decision (here in Korean) was passed by Korea’s Intellectual Property Trial and Appeal Board (IPTAB) last week after Samsung Bioepis filed an invalidation action against AbbVie in March 2015.
“We welcome IPTAB’s decision to invalidate AbbVie’s adalimumab indication patent,” Samsung Bioepis said in an official statement.
“We believe this decision is an important step towards increasing patient access to medicines that enhance the quality of life for autoimmune patients in Korea. We will continue to take the measures necessary to ensure our affordable, high-quality biosimilars will reach the patients who need them most.”
As part of the biosimilar approval process in Korea, originator drug makers must provide a list of patents to the biosimilar maker. For Humira, AbbVie listed eight patents.