Biosimilar updates for the fortnight ending 7 Feb 2020 include the following:
27 Jan 20: Health Canada approvedulcerative colitis as an additional indication for Stelara® (ustekinumab).
On 31 Jan 2020 Pfizer announced it had received a positive CHMP opinion for Ruxience® (biosimilar rituximab) in EU.
3 Feb 2020, the FDA released draft guidance on promotional labelling and advertising for biosimilars, inviting comments from industry until 2 April 2020.
3 Feb 2020: Bio-Thera announced the results for biosimilar BAT1706 (bevacizumab candidate) including that BAT1706 met the primary endpoint in PhIII clinical trials.
3 Feb 2020: The US FDA and FTC announcedjoint efforts to facilitate update of biosimilars, and deter anti-competitive behaviour in the biopharma industry.
5 Feb 2020: Merck announced a new spin-off company which will incorporate products from its Women's Health, Legacy Brands and Biosimilars businesses. The company is yet to be named but will be independent and publicly traded with the transaction expected to be completed in Q1/2 2021.