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Alvotech signs agreement for ustekinumab biosimilar Stelara in Japan

Iceland-based biopharmaceutical company Alvotech and Japan-based Fuji Pharma announced on 9 April 2019 that they had made a binding agreement for the exclusive partnership and supply to commercialize Alvotech’s ustekinumab biosimilar, Stelara, in Japan.

Alteogen gains patent on SC trastuzumab biosimilar

South Korean biologicals company Alteogen announced on 27 March 2019 that it had gained a patent for a subcutaneous version (ALT LS2) of its candidate trastuzumab biosimilar (ALT L2).

First Chinese biologicals maker receives EMA GMP certification

China-based WuXi Biologics announced on 20 March 2019 that it had received good manufacturing practice (GMP) certification from the European Medicines Agency (EMA).

Momenta to reduce its biosimilars programmes

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 1 October 2018 that it would be focusing on two key biosimilars and quit the development of five others.

Belgian companies make biosimilars agreement

Belgian companies SYnAbs and Univercells announced on 20 April 2019 the signing of a service agreement for an undisclosed monoclonal antibody biosimilar.

Celltrion has renewed success with leukaemia biosimilar Truxima and expands markets in Europe and Latin America

In recent months, South Korean biosimilars firm Celltrion has announced a series of successes, including winning a patent case against Samsung Biogen and expansions in the European and Latin American markets.

Novo Nordisk granted exclusivity on GLP-1 agonist Victoza until 2023

Novo Nordisk has announced a settlement with Teva Pharmaceuticals (Teva) giving the company at least four years before it has to compete with biosimilar versions of its diabetes injectable Victoza (liraglutide).

AbbVie and Coherus sign licensing deal for Humira biosimilar

Coherus BioSciences (Coherus) announced in January 2019 that it had entered into global settlement agreements with AbbVie which resolve all pending disputes related to CHS-1420, Coherus’s proposed biosimilar of AbbVie’s Humira (adalimumab).

Under the terms of the settlement, Coherus will have global non-exclusive licence rights to commercialize CHS-1420 and will pay royalties to AbbVie. The licence period for CHS-1420 in the US will begin on 15 December 2023.

Fujifilm acquires Biogen Hillerød facility for US$890 million

On 12 March 2019, Biogen announced that it had entered into an agreement with Fujifilm Corporation under which Fujifilm will acquire Biogen Manufacturing ApS from Biogen for up to US$890 million in cash. Biogen Manufacturing ApS is a large-scale biologicals manufacturing site located in Hillerød, Denmark (Biogen Hillerød). Biogen Hillerød will become Fujifilm's fourth biopharmaceutical contract development and manufacturing site upon closure of this transaction, which is expected in August 2019 subject to closing conditions. The existing workforce at the site, consisting of approximately 800 employees, will continue employment under Fujifilm. 

Boehringer wins access to Humira documents as Janssen’s Remicade is relisted in Quebec

Boehringer Ingelheim is the only biosimilar manufacturer still challenging AbbVie’s Humira (adalimumab) patents in court, and has just won a legal battle to gain access to documents AbbVie has fought hard to keep private. Meanwhile, Janssen has had Remicade (infliximab) reinstated on Quebec’s List of Medications after a decision by the Minister of Health and Social Services to “delist” Remicade was declared invalid and overturned. 

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