Biosimilars

The FDA recently approved Amgen’s Wezlana (ustekinumab-auub) for various inflammatory conditions, marking the first biosimilar approval referencing the popular J&J drug Stelara (ustekinumab). Wezlana, mirroring its reference product, is approved for treating multiple inflammatory diseases in adults, including m...

Aktis Oncology Raises USD 84 Million To Advance Novel Targeted Alpha Radiopharmaceuticals Aktis Oncology has raised an additional USD 84 million in its Series A round, adding to the USD 72 million raised last year to help bring its radiopharmaceuticals to market. The extension to the first round included Merck's...

US FDA grants 510(k) clearance to Motus GI’s Pure-Vu EVS System On February 15, 2022, The Pure-Vu® EVS System received 510(k) clearance from the US Food and Drug Administration, according to Motus GI Holdings, Inc., a medical technology company that provides endoscopy solutions that improve clinical outcomes and...

Sandoz Launches generic Revlimid in 19 European Countries, Bringing a Flood of Competition to BMS' Megablockbuster Since Bristol Myers Squibb acquired Celgene and its megablockbuster Revlimid, the company has been bracing for the day when the multiple myeloma superstar would face generic competition. Sandoz, a s...

The Biosimilars market is growing at a breakneck pace. The biosimilar market provides a compelling economic value proposition. This has been a considerable element in expanding the biosimilar market, and the future of this sector appears promising. Many pharmaceutical companies from across the globe are proactively...

The expiration of many biologic drugs patents has sparked biosimilar development and boosted the biosimilar market growth. Biosimilars are alternative versions of innovator biologic drugs. These are biological products that are similar replicas of the biopharmaceuticals that inspired them. Biosimilars are sometimes...

Teva looks to sell generics in China through joint venture with Guangzhou Pharma As the world’s largest generics maker, Teva still doesn’t have much of a presence in China, even though it is a country relies heavily on generics. The Israeli company is looking to remedy that as Teva has said it “has no agreement with...

Merck sells biosimilars business to Fresenius Merck has divested its biosimilars business to fellow German drug maker Fresenius in a deal potentially worth 670 million euros. The drug maker said the move is aligned with a strategy of focusing on innovative medicines while enabling it to exploit its biosimilars portf...

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally. On 27 June 2014, the European Medicines Agency’s (EMA’s) Committee for Medicinal Produc...