Biosimilars revenue trends
In 2Q17, Biogen’s (BIIB) biosimilars franchise reported revenue of ~$91 million, compared to $31 million in 2Q16. In 2Q17, the company’s biosimilars business witnessed a 37% rise on a quarter-over-quarter basis.
Biogen’s Benepali, a biosimilar to Amgen’s (AMGN) Enbrel, is currently available in 20 countries. Benepali’s share of the etanercept market surpassed 30% in Germany in 2Q17. Biogen estimates that currently, ~50,000 patients in Europe are on Benepali therapy. Biogen’s Flixabi, a biosimilar of Johnson & Johnson’s (JNJ) Remicade, is currently available in eight markets.
The growth in Biogen’s biosimilars business could boost the share price of the iShares Edge MSCI USA Quality Factor ETF (QUAL). Biogen makes up ~1.4% of QUAL’s total portfolio holdings.
The above graph represents the revenue curve of Biogen’s biosimilars portfolio from 2Q16 to 2Q17.
Biosimilars in the pipeline
In June 2017, Biogen’s Imraldi, a biosimilar of AbbVie’s (ABBV) Humira, received a positive opinion from the European Medicines Agency’s (or EMA) Committee for Medicinal Products for Human Use (or CHMP). CHMP’s opinion will be sent to the European Commission for marketing authorization in the European Union. Regulatory approval for Imraldi should strengthen Biogen’s biosimilar portfolio and propel its revenue growth.
Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, develops, manufactures, and commercializes biosimilar therapies. Samsung Bioepis is conducting a phase 3 clinical trial for SB8, a biosimilar candidate of Avastin (bevacizumab). The EMA accepted Samsung Bioepis’s SB3, a biosimilar candidate referencing Herceptin (trastuzumab) in October 2016. Success in a clinical trial will help Samsung Bioepis to file regulatory approvals in different countries and commercialize its biosimilars.