Read our latest updates & insights

The Korea Herald has reported that Samsung Bioepis, through partner Biogen launched its Lucentis® (ranibizumab) biosimilar SB11 in February 2023 in Germany.   The product is sold as Byooviz™ in Europe and Ameliv™ in Korea.  Byooviz™ was launched in the US on 2 June 2022. 

Regeneron announced that the FDA has accepted for priority review its BLA for aflibercept 8mg for treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.  The BLA was supported by two pivotal trials demonstrating non...

The EMA CHMP has recommended a grant of market authorization for Bekemv®, Amgen’s eculizumab biosimilar to Alexion’s Soliris® (eculizumab). Bekemv is indicated for the treatment of paroxysmal nocturnal haemoglobinuria in adults and children.

AstraZeneca has announced that its Imfinzi® (durvalumab) and Imjudo® (tremelimumab) immunotherapy combination has been approved in the EU for first-line treatment of advanced liver and lung cancers. The approval follows recommendations by the EMA human medicines committee i...

MSD and Moderna announced a new investigational mRNA cancer vaccine mRNA-4157/V940 combined with Keytruda® (pembrolizumab) has been granted Breakthrough Therapy Designation by the FDA for adjuvant treatment of patients with high-risk melanoma following complete resection. T...

Eli Lily has published its annual financial report, noting that the there was a 12% increase in revenue in the US, and 13% increase outside of the US, from sales of Taltz® ixekizumab. The annual report discloses that Eli Lily derived more than US$2.48 billion from the suppl...

South Korea’s Alteogen announced that its subsidiary Altos Biologics has completed patient enrolment in its Ph III trials of ALT-L9 aflibercept (biosimilar to Regeneron’s Eylea®) in patients with neovascular  age-related macular degeneration.  Alteogen reported that it plan...

The Financial Times has reported that the Dutch Pharmaceutical Accountability Foundation (PAF), a public interest group, is suing Abbvie for allegedly overcharging citizens for Humira® (adalimumab) in Holland. PAF is arguing that the pricing of the drug is in breach of huma...

Significant biosimilar activities this week include:

18 Feb 23 | Takeda publishes results of Ph III trials of vedolizumab in preventing intestinal acute graft-versus-host disease

Takeda published the results of Ph III trials of vedolizumab in the prevention of...