Read our latest updates & insights

On 21 April 2024, Swedish biosimilar developer Xbrane announced that the FDA issued a Complete Response Letter (CRL) regarding its BLA for ranibizumab biosimilar XlucaneTM.  The issues identified primarily concern (a) the analytical methods for the reference standard; and (...

Dr Reddy’s announced that the FDA has issued a Complete Response Letter (CRL) regarding its BLA for biosimilar rituximab (DRL_RI), biosimilar to Genentech/Biogen’s Rituxan®.   The CRL is said to relate to the ongoing resolution of results of regulatory inspections at Dr Red...

On 19 April 2024, Merck (known as MSD outside Canada and the US) announced that Health Canada has approved Keytruda® (pembrolizumab) as a 1st line treatment for locally advanced unresectable or metastatic HER2 negative gastric cancer or gastroesophageal junction adenocarcin...

On 19 April 2024, Alvotech announced that it has entered a long-term agreement with an unnamed strategic partner to market in the US its high concentration interchangeable adalimumab-ryvk (AVT02), biosimilar to AbbVie’s Humira®, which received FDA approval in February 2023....

On 19 April 2024, Nora Pharma (subsidiary of Sunshine Biopharma) announced its entry into the biosimilars market with Health Canada’s approval of Niopeg® (peg-filgrastim), a biosimilar product comparable to Amgen’s NEULASTA®.
This follows Coherus’ la...

On 18 April 2024, Takeda announced FDA approval of subcutaneous administration of ENTYVIO® (vedolizumab) for maintaining therapy in adults with moderately to severely active Crohn’s disease (CD).
This follows the FDA’s acceptance of Takeda’s BLA for ENTYVI...

On April 2024, Korean Biomedical Review reported that Celltrion won the Denmark national tender for its subcutaneous infliximab formulation, Remsima SC®.  Remsima SC® (infliximab) will be supplied in Denmark for one year by Celltrion’s Danish subsidiary. This subsidia...

On 17 April 2024, Biocon announced that it signed an exclusive licensing and supply agreement for generic Ozempic® (semaglutide) in Brazil.  Biocon will develop, manufacture and supply the semaglutide product and Biomm is responsible for regulatory and commercialisation str...

On 16 April 2024, Alvotech announced the US has approved SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara®(ustekinumab), for both adult and paediatric use. Selarsdi™ was developed by Alvotech and will be commercialised by Teva in the US.
This is the second US biosi...

The Korea Biomedical Review reports that, on 16 April 2024, Merck Sharp & Dohme (MSD) announced that it obtained approval in Korea for an expanded indication for its Keytruda® (pembrolizumab) as a combination therapy with chemoradiotherapy for treating FIGO (Internation...