Pipeline Updates from Clover, Pfizer, and Mylan/Biocon - Big Molecule Watch

Clover Biopharmaceuticals, a clinical-stage biotech company based in Chengdu, China, and General Electric announced last week that Clover had selected General Electric’s FlexFactory biomanufacturing platform for Clover’s new manufacturing facility, to be located in the Changxing Economic and Technological Development Zone.  The facility, which is scheduled to open in the second half of 2018, will feature two 2,000 liter bioreactors from GE.  The first product slated for manufacture at the new facility is a biosimilar of Enbrel® (etanercept) for the treatment of rheumatoid arthritis.  As previously reported here, in addition to Clover, GE has entered into agreements regarding its FlexFactory technology with Arven Pharmaceuticals in Turkey and Dr. Reddy’s in India.

Pfizer announced last week that PF-05280586, its potential biosimilar for Rituxan® (rituximab-US)/MabThera® (rituximab-EU), had met its prior endpoint in the REFLECTIONS B3281006 trial.  REFLECTIONS B3281006 was a randomized, double-blind clinical trial evaluating the efficacy, safety, pharmacokinetics, and immunogenicity of PF-05280586 versus MabThera®.  According to Pfizer, the trial showed the overall response rate (ORR) for patients with CD20-positive, low tumor burden, follicular lymphoma was equivalent for PF-05280586 and MabThera®.  Pfizer also reported that PF-05280586 is one of seven potential biosimilars that Pfizer has in mid- to late-stage development.

Yesterday, Mylan and Biocon announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending approval for the long-acting insulin analog SemgleeTM (insulin glargine), which, under the EMA classification, is a potential biosimilar of Lantus.  The positive CHMP opinion will be reviewed by the European Commission, which is expected to render a decision on approval in April of this year.  Glargine is one of three insulin analogs that has been co-developed by Mylan and Biocon, as part of their exclusive partnership related to biosimilars and insulin analogs.  In addition to the EU, Mylan and Biocon have also sought approval in Australia, Canada, and the United States.

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