Read our latest updates & insights

MSD announced that Ph III trials of Keytruda® (pembrolizumab) in combination with chemotherapy met its primary endpoint of progression-free survival for the treatment of stage III-IV or recurrent endometrial carcinoma.  Reportedly, the safety profile of Keytruda was consist...

Fresenius Kabi and Formycon AG announced they have reached a global license agreement to commercialise FYB202, biosimilar to Johnson & Johnson’s Stelara®. Under the agreement, Fresenius will have the exclusive commercialisation rights in key global markets, whilst Formy...

Roche’s Genentech is investing US$450M in expanding its biologics capabilities at Oceanside California. Approximately US$280M will go toward building a new biologics manufacturing facility that will begin operations in 2025. The new facility will produce protein-based medic...

Reuters reported that it expects only limited cost savings to result from Amgen’s launch of Amjevita® (biosimilar to AbbVie’s Humira® adalimumab) in the US in January this year.  Reuters reported that while Amgen launched Amjevita at two price points (one with a 5% discount...

The much anticipated launch of the first US Humira biosimilar occurred with Amgen launching Amjevita® (adalimumab) on 31 January 2023, pursuant to its settlement agreement with AbbVie which was penned in September 2017.  Amjevita® is the first adalimumab biosimilar to be la...

A CVS report has predicated that interchangeability designations for adalimumab biosimilars will not primarily drive their adoption by prescribers.  This contradicts the Cardinal Health 2023 Biosimilars Report, which found that a majority of providers intended to only presc...

Significant biosimilar activities this week include:

24 Jan 23 | Saudi Food & Drug Authority approves Alvotech’s Simlandi® (biosimilar adalimumab)

Alvotech and Bioventure announced that the Saudi Food & Drug Authority has approved the manufacture and d...

The EC approved Sanofi’s Dupixent® (dupilumab) for the treatment of eosinophilic esophagitis (EoE).  Dupixent is the first medicine specifically indicated to treat EoE in Europe and the US.

The CHMP adopted a positive opinion recommending the approval of a citrate-free high concentration formulation of Hyrimoz® (adalimumab), biosimilar to AbbVie’s Humira®.  The positive opinion relates to all indications in the reference product, Humira®.  Hyrimoz was first ap...

Australia’s PBAC recommended amending the circumstances under which Roche’s Actemra® (tocilizumab) is available for reimbursement via the PBS.  The new PBS listing of Actemra includes ultrasound in the clinical criteria as a method for diagnosis of giant cell arteritis.