Biosimilars
Pharmacovigilance for biologicals in The Netherlands
Escher is an independent regulatory research platform run by Netherlands-based research enabler TI Pharma. The group recently published a paper in the journal Drug Safety on the traceability of biologicals in clinical practice and adverse drug reaction (ADR) reporting [1]. This paper concludes that in The Netherlands brand names are not routinely recorded in clinical practice and batch numbers are poorly recorded. The findings suggest that the limited traceability of brand names and batch numbers in ADR reports for biologicals may be primarily caused by the shortcomings in the recording and tracing of information in clinical practice.
Launch of partnership for biosimilars education and access
The Biosimilars Forum announced on 1 February 2016 the launch of a new biosimilars education initiative. The ‘Partnership for Biosimilars Education and Access’ will focus on raising awareness and encouraging access to biosimilars in the US.
Kyowa to market Sandoz’s rituximab biosimilar in Japan
Biotech firm Kyowa Hakko Kirin (Kyowa) announced on 25 January 2016 that it had made a deal with Sandoz, the generics division of Novartis, for exclusive marketing rights to Sandoz’s biosimilar rituximab in Japan.
Adalimumab biosimilar meets primary endpoint in pharmacokinetic study
On 21 December 2015, Baxalta, a spinoff company from Baxter International, and US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced positive results from a pharmacokinetic study with their candidate adalimumab biosimilar M923.
Biosimilar etanercept offered at 47% discount in Norway
Samsung Bioepis confirmed on 1 February 2016 that it had won a contract in Norway to supply its newly approved biosimilar etanercept, Benepali, to the country.
Positive phase III results for cetuximab and infliximab copy biologicals
US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 11 January 2016 that its partner, MabTech had successfully completed phase III clinical trials in China for STI-001, a copy biological for cetuximab (Erbitux) and STI‑002, a copy biological for infliximab (Remicade). Both STI-001 and STI-002 met their primary endpoints in confirmatory, randomized, controlled, two-part phase III studies.
Lack of health insurance limits access to biologicals in India
One example of a negative driver of the ‘similar biologics’ market in India is the lack of health insurance in the country [1].
Australian approval for infertility biosimilar Bemfola
Switzerland-based Finox Biotech (Finox) announced on 30 November 2015 that it had gained approval from Australia’s drug regulator, the Therapeutic Goods Administration (TGA), for follitropin alfa biosimilar Bemfola.
Prescribing similar biotherapeutic products in Latin America
Prescribing practices vary across different countries in Latin America and reveal gaps in understanding and in the use of distinguishable names for biologicals [1].
Biosimilars applications under review by EMA – December 2015
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.