Update on Biosimilar Launches and Development

Biocon announced yesterday that it has received marketing authorization approval from the European Commission for Semglee™ (insulin glargine). The decision came after receiving a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. According to the press release, this is the first biosimilar from Biocon and Mylan’s joint portfolio to be approved in Europe. Biocon also announced that Semglee™ has been approved by the Therapeutic Goods Administration (TGA) in Australia and that marketing applications for Semglee™ have been submitted in Canada and the United States.

As we previously reported, Pfenex decided late last year to halt development of PF582 and PF529, biosimilar candidates to Lucentis® (ranibizumab) and Neulasta® (pegfilgrastim), respectively. However, according to company statements during its Q4 2017 earnings call, Pfenex is looking for a partner to re-initiate these programs. Discussing the PF582 and PF529 development programs, CEO Evert Schimmelpennink stated that “the most prudent path for the development is a collaboration with a strategic development partner. As that business development process continues, we continue to seek partners with whom we would advance those programs.”

On March 8, the Korea Herald reported that GC Pharma was granted regulatory approval to launch Glarzia Prefilled Pen in Korea, a biosimilar to Sanofi’s Lantus® (insulin glargine).  According to the report, GC Pharma holds marketing rights for Glarzia in Korea under a licensing deal with Biocon, and Glarzia will be the second Lantus® biosimilar launched in Korea, following Eli Lilly’s and Boehringer Ingelheim’s Basaglar.

On March 9, TRPharm announced that it was ready to launch REDDITUX (rituximab) in Turkey. According to the press release, REDDITUX is a product of a collaboration between TRPharm and Dr. Reddy’s under which TRPharm will market a total of three biosimilar products from Dr. Reddy’s in Turkey. TRPharm states that, upon the completion of its facility investment, it will also manufacture the drug substance and drug product in Turkey.

On March 18, the Korea Herald reported that LG Chem obtained regulatory approval to market Eucept, its biosimilar to Amgen’s Enbrel® (etanercept). The report indicates that Eucept is the second Enbrel® biosimilar launched in Korea, coming three years after Samsung Bioepis’ Brenzys.