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Boehringer Ingelheim announced that the FDA has approved an autoinjector pen presentation of its Cyltezo® (adalimumab-adbm), an FDA-approved interchangeable biosimilar to AbbVie’s Humira® (adalimumab). Cyltezo® is indicated for multiple chronic inflammatory diseases.  The a...

Biogen and Eisai announced that Eisai submitted a marketing authorisation application (MAA) for LEQEMBI® (lecanemab) to the UK Medicines and Healthcare products Regulatory Agency (MHRA).  LEQEMBI® is an investigational anti-amyloid beta protofibril antibody indicated for th...

A study published in the New England Journal of Medicine has found that patients with chronic obstructive pulmonary disease (COPD) and type 2 inflammation who received Dupixent® (dupilumab) had fewer exacerbations, better lung function and quality of life, and less severe r...

Alvotech has provided updates on some of its biosimilar products in its report on its financial results for the first 3 months of 2023.

As previously reported, Alvotech initiated a confirmatory patient study for AVT05, its proposed biosimilar to Simponi® and Simpon...

The US Supreme Court handed down its decision in Amgen v Sanofi, relating to the enablement requirement.  Amgen filed the Supreme Court petition in response to a Federal Court decision which invalidated genus claims in two Amgen patents relating to Repatha® (evolocumab) whi...

Teva announced its new strategic framework and “Pivot to Growth” strategy which aims to bolster the Company’s strong commercial portfolio with products including biosimilars. Biosimilars are part of Teva’s ‘accelerate growth’ stage between 2025-2027.  The company intends to...

The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending AbbVie’s Rinvoq® (upadacitinib) as an option for eligible adults with moderate to severe active Crohn’s disease (CD) on the NHS in England and Wales.  It is the first j...

The FDA has approved AbbVie’s RINVOQ® (upadacitinib) for adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.  RINVOQ® is the first oral treatment approved to this in...

Amneal announced it has launched FLYNETRA™ (pegfilgrastim) in the US, biosimilar to Amgen’s Neulasta®.  FLYNETRA™ is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive a...