Biosimilars
Australia’s PBAC recommends substitution of adalimumab biosimilars
Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the adalimumab biosimilars Amgevita and Hadlima ‘should be treated as equivalent’ to the brand-name biological Humira on the Australian Pharmaceutical Benefits Scheme (PBS).
Tanvex BioPharma submits filgrastim biosimilar to Health Canada
Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) announced on 16 January 2019 that it had submitted a biosimilar application to Health Canada for its proposed filgrastim biosimilar TX01.
Liability chain of biosimilar switching
When an adverse event to a medicinal product, or a loss of efficacy, is experienced by a patient, the liability chain may potentially involve both the manufacturer and/or Marketing Authorization Holder (MAH) (products liability) and the healthcare professionals responsible for prescribing, dispensing and/or administrating (professional liability) the medicine.
FDA approves trastuzumab biosimilar Herzuma
On 14 December 2018, the US Food and Drug Administration (FDA) approved the trastuzumab biosimilar, Herzuma (trastuzumab-pkrb), for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer.
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 - to switch or not to switch
Authors Marc Scherlinger and Thierry Schaeverbeke commented on the paper from Glintborg and co-authors ‘To switch or not to switch’ ,which reported the results of biosimilar etanercept switching in Denmark [1].
FDA approves trastuzumab biosimilar Ontruzant
On 18 January 2019, the US Food and Drug Administration (FDA) approved the trastuzumab biosimilar, Ontruzant (trastuzumab-dttb), for the treatment of patients with breast and gastric cancer.
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.
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.
Positive phase III results for rituximab biosimilar CT-P10
Celltrion has presented positive phase III results for its rituximab biosimilar CT‑P10 at the American Society of Hematology Meeting (ASH) annual meeting.
