Biosimilars
FDA approves Mylan’s adalimumab biosimilar Hulio
The US Food and Drug Administration (FDA) has approved Mylan/Fujifilm’s adalimumab biosimilar Hulio (adalimumab-fkjp) on 7 July 2020. The product is the sixth adalimumab biosimilar to be approved by FDA and is manufactured by Japan-based Fujifilm Kyowa Kirin Biologics.
Quotas improve biosimilar use in Germany
An assessment of the role of cost control measures on biological drugs in Germany finds that quotas for biosimilars are in some cases associated with increased use and are overall more effective than priority prescribing [1].
New Zealand IBD charity releases position statement on biosimilars
The charity Crohn’s and Colitis New Zealand has released a position statement on biosimilars, although there are not yet any biosimilars for inflammatory bowel disease (IBD) on the market in New Zealand.
Celltrion launches Truxima in Brazil
On 27 May 2020, South Korean biotechnology company Celltrion Healthcare (Celltrion) announced that it had launched its rituximab similar biotherapeutic product Truxima (CT‑P10) in Brazil.
Biosimilars applications under review by EMA – July 2020
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.
Canada approves infliximab and filgrastim biosimilars Avsola and Nivestym
Canada’s drug regulator, Health Canada, has approved the infliximab and filgrastim biosimilars Avsola (ABP 710) and Nivestym.
Denmark achieves 83% reduction in adalimumab costs through switching
Spending on adalimumab in Denmark decreased by almost 83% between September and December 2018, thanks to a mandatory switching policy.
Revance and Mylan move forward with Botox biosimilar
US firm Revance Therapeutics (Revance) announced on 1 June 2020 that its partner, US-based drugmaker Mylan, had decided to move forward with a development plan, under a 351(k) pathway, for a proposed biosimilar to Allergan’s cosmetic blockbuster Botox and Botox Cosmetic (onabotulinumtoxinA).
Japanese approval for first adalimumab biosimilar
Japan-based Fujifilm Kyowa Kirin Biologics announced on 29 June 2020 that it had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its adalimumab biosimilar FKB327 in Japan.
Biosimilars in Belgium: increasing competition
Competition following the entry of biosimilars is still limited in Belgium, which is mirrored in low biosimilar market shares. Although (short-term) cost savings are realized by the implementation of mandatory price reductions on originator medicines (and obtaining high biosimilar market shares should thus not be a goal in itself), biosimilars can play a key role in ensuring the long-term sustainability of the Belgian off-patent biologicals market.
