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Outlook Therapeutics announced that it has re-submitted its BLA for ONS-5010 LYTENAVA™ (bevacizumab-vikg, ophthalmic formulation) for wet AMD to the FDA.  Outlook first submitted its BLA in March 2022, however withdrew it in May 2022 following requests from the FDA for addi...

Significant biosimilar activities this week include:

23 Aug 22 | Amgen announces the results of Ph III eculizumab trials

Amgen announced the results of a Ph III study evaluating the efficacy and safety of ABP959 (proposed eculizumab biosimilar) compared with S...

MSD announced that it will present data on several oncology medicines at the European Society for Medical Oncology (ESCO) Congress in Paris from 9-13 September, including relating to KEYTRUDA® (pembrolizumab) and PADVEV® (enfortumab vedotin).

Moderna has announced that it commenced proceedings against Pfizer and BioNTech in both the U.S. District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany last Friday seeking damages for patent infringement relating to the Pfizer/BioNT...

Merck & Co., Inc., is reportedly in negotiations to acquire Seagen Inc (previously known as Seattle Genetics, Inc), with negotiations presently having stalled due to a failure to agree on price.  The acquisition could give Merck & Co., Inc., access to Seagen’s pipel...

Formycon announced that the European Commission has approved Ranivisio®, biosimilar to Lucentis®/ranibizumab developed by Bioeq (which is a joint venture between Formycon and Polpharma Biologics).  Ranivisio is EC approved for the treatment of neovascular (wet) age-related ...

Alvotech announced that it has commenced a confirmatory patient study for AVT03 (biosimilar to Prolia® and Xgeva®, denosumab).  The objective of the study is to demonstrate clinical similarity of AVT03 to Prolia® in terms of efficacy, safety, immunogenicity and pharmacokine...

Novartis announced that it will spin off Sandoz into a new publicly traded standalone company.  The new company will be headquartered in Switzerland and will be listed on the SIX Swiss Exchange, with an American Depositary Receipt program.  Novartis reported that this separ...

STADA published its first half 2022 financial results, reporting a 15% increase in adjusted group sales.  Adjusted for currency fluctuations and special effects, earnings before interest, tax, depreciation and amortisation (EBITDA) improved by 23% to €386.5 million.  STADA ...

Lupin announced that it has entered into an exclusive licensing agreement with I’rom Group for biosimilar denosumab in Japan.  Under the agreement, I’rom and Lupin will together conduct clinical trials and obtain registration, and I’rom will then exclusively distribute and ...