STADA and SBP Group have launched a strategic biosimilars partnership beginning with a proposed Keytruda biosimilar and providing a framework for up to three additional programmes.

The conditional marketing approval introduces a new intravenous abatacept biosimilar for patients with moderate to severe rheumatoid arthritis or active psoriatic arthritis who have responded inadequately to other disease-modifying treatments.

The MHLW marketing approval adds a Neulasta biosimilar to Biocon’s Japanese portfolio, with Sandoz K.K. responsible for its exclusive promotion, sale and distribution in the country.

The supplemental approval introduces a new self-injection option for patients receiving Yesintek across its approved autoimmune indications without changing the medicine's existing therapeutic uses.

The portfolio collaboration combines Henlius’ biologics development and manufacturing capabilities with Sandoz’s ex-China commercial infrastructure, initially covering three biosimilars and an option on a recombinant human hyaluronidase programme.

The completed transaction combines Kashiv’s biologics R&D and manufacturing capabilities with Amneal’s commercial infrastructure, giving the company end-to-end control across biosimilar development, production and commercialisation.

The approval adds another US biosimilar option for rituximab-treated conditions, including non-Hodgkin lymphoma and chronic lymphocytic leukaemia, although commercial availability and pricing have not yet been confirmed.

The approval expands Accord BioPharma's oncology supportive care portfolio, making it the only US company to offer two pegfilgrastim biosimilars alongside a filgrastim biosimilar.