AbbVie’s mega-blockbuster Humira is facing biosimilar competition, but another patent licensing agreement, this time with Mylan, sees the company securing exclusivity through to 2023 in the US.
South Korea’s SFC has alleged that Samsung BioLogics had intentionally omitted information regarding the joint venture agreement with Biogen that created Samsung Bioepis.
Long-awaited interchangeability guidance will strengthen the public’s confidence in biosimilars, but is likely to only affect 20% of all biological products, MedImmune and Biocon said at CPhI.
Brexit would create regulatory uncertainty, delay the launch of biosimilars and prevent NHS cost savings according to the newly founded British Biosimilars Association (BBA).
Is the debate surrounding unique international nonproprietary names (INNs) for biosimilar products a delaying tactic driven by reference biologic makers? One market analyst believes so.
With the release of three final guidance documents on biosimilars, the FDA is offering more clarity for developers seeking to fine-tune their understanding of the science and quality of biosimilars.
Celltrion has emphasised the savings Remsima ((inflizimab) could offer at a conference in Spain as partner Napp Pharmaceuticals prepares to extend the roll out of the Remicade biosimilar to the UK.
Like the US and EU, China’s SFDA is looking to ensure that approved biosimilars are proven to be similar to their reference drugs, according to an unofficial translation of the guideline by BioCentury.
Almost all of the biosimilars currently approved have been developed using a third-party research organisation according to a survey from the Association of Clinical Research Organizations (ACRO).
As Celltrion announced Monday that it filed the first monoclonal antibody for approval with the US FDA, investor groups are crying foul over some of the tactics used by others in industry to discourage the uptake of biosimilars in the US.
Biosimilars are not analogous to small molecule generics in terms of market share loss according to Johnson & Johnson, which is confident its biopharmaceutical portfolio can withstand competition.
