Biosimilars
Hospira and Pfenex to collaborate on ranibizumab biosimilar
US-based injectables specialist Hospira and US biotechnology firm Pfenex announced on 10 February 2015 that they had entered into an agreement to exclusively develop and commercialize for worldwide sales PF582 (ranibizumab), Pfenex’s leading biosimilar candidate.
Biosimilars compared to generics in the European market
Once a patent expires, price competition is possible since any manufacturer can copy the originator product. This circumstance justifies the place in the pharmaceutical market for generics and biosimilars, i.e. off-patent medicines to be sold at lower prices than their originators [1].
FDA advisers to consider infliximab biosimilar
The US Food and Drug Administration (FDA) revealed in a Federal Register publication on 10 February 2015 that it has asked advisers to review a second biosimilar application.
Biosimilars of infliximab
Last update: 27 November 2020
Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.
Torrent licenses three ‘similar biologics’ from Reliance
Torrent Pharmaceuticals (Torrent) announced on 25 December 2014 that it had made an exclusive licensing agreement with fellow Indian drugmaker Reliance Life Sciences (Reliance) for the marketing of three ‘similar biologics’ in India.
Impact of nephrology subsequent entry biologics in Canada
Subsequent entry biologics (SEBs) may soon be a reality in Canadian nephrology practice. Along with opportunities to reduce healthcare costs, these agents pose unique challenges to successful implementation. Understanding the experiences around the globe in both regulatory affairs and implementation will be a valuable guide for Canadian clinicians. This review should assist clinicians and policymakers to navigate this complex subject and to make informed decisions in the best interest of their patients [1].
Hanwha to transfer biosimilar etanercept technology to Merck KGaA
South Korea’s Hanwha Chemical Corporation (Hanwha) has reportedly signed a contract with German drug maker Merck KGaA (Merck Group) to export the technology to make its biosimilar etanercept drug.
Japanese approval for insulin glargine biosimilar
Partners Eli Lilly and Boehringer Ingelheim confirmed on 19 January 2015 that they had received Japanese regulatory approval for their biosimilar insulin glargine product (LY2963016).
No relevant difference in ADRs from biosimilars and originators
A study of adverse drug reactions reported in Italy has shown no difference between the number and type of side effects reported for biosimilars and their corresponding originators [1].
Biosimilars applications under review by EMA – December 2014
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.
