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Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the US and Canada) announced it has filed a Form 10 registration statement with the US Securities and Exchange Commission in relation to its intended biosimilars and women’s health spinoff, Organon. Merck &a...

Alvotech announced it has completed a second round of its US$100 million private placement.  In the first round, Alvotech raised US$65 million, including investments from Korea’s Shinhan, US’ Baxter Healthcare SA, and Germany’s ATHOS.

Korea Biomedical Review reported that Samsung Bioepis has entered an agreement with Yuhan Corp for the commercialisation of Adalloce™ (biosimilar adalimumab) in South Korea. Adalloce™ is marketed in Europe as Imraldi®.

The US Senate unanimously passed the Ensuring Innovation Act and the Advancing Education on Biosimilars Act.

The Ensuring Innovation Act aims to stop ‘evergreening’ by preventing pharmaceutical companies from claiming new innovations when they make insign...

Lannett announced it had received comments from the FDA related to the pivotal trial protocol and statistical analysis plan for its biosimilar insulin glargine program. Lannett said that it was comfortable with the feedback, and remains on track to submit an IND to the FDA ...

Korea Biomedical Review reported that Alteogen has completed Ph I trials of ALT-L9 (proposed aflibercept biosimilar).

On 4 March 2021, the Australian TGA approved Pfizer’s Abrilada®, biosimilar to AbbVie’s Humira® (adalimumab) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, as well as Crohn’s disease, ulcerative colitis...