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Amgen sues Hospira in the District Court of Delaware, alleging Hospira’s aBLA for a proposed pegfilgrastim biosimilar infringes Amgen’s Neulasta patent for protein purification (no. 8,273,707).​

Significant biosimilar activities this fortnight include
05 Feb 20 | 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 ...

MSD 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 Q1/2 202...

The US FDA and FTC announced joint efforts to facilitate update of biosimilars, and deter anti-competitive behaviour in the biopharma industry.

The FDA released draft guidance on promotional labelling and advertising for biosimilars, inviting comments from industry until 2 April 2020.

Bio-Thera announces BAT1706 (bevacizumab candidate) met the primary endpoint in Ph III clinical trials.

On 31 Jan 2020 Pfizer announced it had received a positive CHMP opinion for Ruxience® (biosimilar rituximab) in EU.

Pfizer announces positive CHMP opinion for Ruxience® .

Health Canada approves ulcerative colitis as an additional indication for Stelara®.

Significant biosimilar activities this week include
Jan 20 | Genentech and Roche commenced recruitment for Ph III clinical trials of their ranibizumab Port Delivery System (PDS) in patients with diabetic macular edema. The PDS uses a refillable eye implant to release ...