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Alteogen wins process patent for aflibercept biosimilar

South Korean biologicals company Alteogen announced on 4 January 2019 that it had been granted a process patent for its method of producing an aflibercept biosimilar, ALT‑L9, referencing Regeneron’s blockbuster drug Eylea (aflibercept). The patent is a novel method for producing the anti-vascular endothelial growth factor (anti-VEGF) fusion protein.

Adalimumab biosimilar Imraldi makes waves in Europe

Korean biosimilars maker Samsung Bioepis has gained more than 60% of the adalimumab market in Germany for its adalimumab biosimilar, Imraldi. But it’s not just Imraldi and not just in Germany, the company’s accumulated sales for three of its biosimilars in Europe reached US$545.2 million in 2018.

Biosimilars of darbepoetin alfa

Last update: 1 February 2019

Darbepoetin alfa is a synthetic form of erythropoietin. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.

Celltrion wins patent suit in Japan over trastuzumab biosimilar

South Korean biotechnology company Celltrion announced on 5 November 2018 that it had won a patent suit in Japan involving its trastuzumab biosimilar, Herzuma (CT‑P6)

Biosimilars makers in Canada to launch patient support programme

Biosimilars Canada, an association representing Canada’s biosimilar makers, announced on 22 November 2018 that it had chosen pharmaceutical service provider Innomar Strategies to be the preferred provider for the association’s Patient Support Program (PSP) platform.

WHO should finalize its BQ guidance

According to authors from the US, the World Health Organization (WHO) should finalize its Biological Qualifier (BQ) guidance. Distinguishable naming will allow quick and accurate tracing of the manufacturer of biologicals, should adverse events occur and improve patient safety by reducing confusion and mishaps. This will ensure that developing nations, including those in the Middle East and North Africa (MENA) region, have access to high quality, affordable medicines [1].

British diabetologists issues position statement on biosimilar insulin

The Association of British Clinical Diabetologists (ABCD) has issued a position statement on the use of biosimilar insulin. The statement summarises information on the advantages and disadvantages of using biosimilar insulins and gives the association’s position on when biosimilar insulins be used [1].

Biosimilars applications under review by EMA – January 2019

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Boehringer Ingelheim and Sandoz abandon biosimilars

Boehringer Ingelheim has decided to abandon biosimilars outside the US. While Sandoz has decided not to pursue biosimilar rituximab in the US.

Merck gains US infliximab contract but drops insulin glargine biosimilar

US pharma giant Merck (known as MSD outside the US and Canada) has signed a deal with the US Department of Veterans Affairs (VA) for its infliximab biosimilar, Renflexis. However, it is pulling out of a deal for insulin glargine biosimilar Lusduna.

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