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The FDA has issued Samsung Biologics with a Form 483 containing six key observations following site inspections on 21-25, 28-31 August and 1 September 2023.  A Form 483 is issued to companies at the conclusion of an FDA inspection if conditions may constitute violations of ...

The US Patent Trial and Appeal Board (PTAB) has instituted Samsung Bioepis’ inter partes review (IPR) against Regeneron’s Eylea® (aflibercept) patent no. 10,888,601 in IPR proceeding IPR2023-00739.  The ‘601 patent relates to methods of use of aflibercept in treating age re...

The Korea Herald reported that Samsung Bioepis has launched Epysqli®, its biosimilar to AstraZeneca/Alexion’s Soliris® (eculizumab) in three European countries.  Samsung Bioepis confirmed it is preparing to launch Epysqli® in France and the Netherlands by the end of 2023.

MSD and Daiichi Sankyo announced a global development and commercialisation collaboration involving Daiichi’s three deruxtecan antibody-drug conjugate candidates: patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan. The companies will jointly develop and...

AstraZeneca and Daiichi Sankyo announced that the European Commission (EC) has approved Enhertu® (trastuzumab deruxtecan) to treat a new indication: monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activa...

AstraZeneca announced that the Chinese National Medical Products Administration (NMPA) has approved Soliris® (eculizumab) to treat a new indication: neuromyelitis optica spectrum disorder (NMOSD).  Soliris® is the first and only complement inhibitor approved for the treatme...

The FDA approved Amgen’s Enbrel® (etanercept) on 18 October 2023 for a new indication: active juvenile psoriatic arthritis (JPsA) in paediatric patients 2 years of age and older.

On 21 March 2023, one of the largest studies to date examining etanercept biosimilar/ori...

On 17 October 2023, AbbVie announced that Health Canada has approved its Rinvoq® (upadacitinib) to for new indication: moderate to severely active Crohn’s disease.  This follows the recent Canadian approval (9 May 2023), of Rinvoq® for the treatment of Active Non-Radiograph...

AstraZeneca announced that the FDA accepted for Priority Review its supplemental New Drug Application (sNDA) for Tagrisso® (osimertinib) in combination with chemotherapy has been accepted and granted Priority Review in the US for the treatment of adult patients with locally...