Biosimilars
FDA rejects Amgen’s trastuzumab biosimilar
Biotech giant Amgen announced on 4 June 2018 that the US Food and Drug Administration (FDA) had rejected the application for approval of its trastuzumab biosimilar.
Biosimilar insulins have same efficacy and safety as reference biologicals
Researchers from the US have found that biosimilar insulins have comparable safety and clinical efficacy as their reference biologicals [1].
Biosimilar infliximab blocked in Australia
Switzerland-based drug giant F. Hoffmann-La Roche (Roche) has gained a temporary order in an Australian Federal Court blocking Sandoz from launching its rituximab biosimilar.
Savings with use of biosimilar trastuzumab for breast cancer patients in Croatia
Breast cancer is worldwide the most common cancer in women. In 2012 alone, there were approximately 464,000 new cases and 131,000 deaths from breast cancer in Europe. In Croatia, breast cancer was the fourth leading cause of death among women and ninth in both sexes in 2016.
Biosimilars and the role of regulatory authorities
According to authors Hye-Na Kang and Ivana Knezevic, from the World Health Organization (WHO), market access to biosimilars can be restricted by several factors [1]:
(i) manufacturing processes may be expensive and complex
(ii) patents on the manufacturing processes of the original product may not have expired
(iii) biosimilar manufacturers may have limited access to data on the original product
(iv) appropriate regulatory frameworks may not be in place
(v) government policies on switching to biosimilars, pricing and reimbursement may be lacking.
Celltrion resubmits biosimilar trastuzumab to FDA
South Korean biotechnology company Celltrion announced on 18 June 2018 that it had resubmitted its application for marketing approval for its candidate trastuzumab biosimilar, CT‑P6, to the US Food and Drug Administration (FDA).
Efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501
Adalimumab is the most commonly prescribed biological and is approved for rheumatoid arthritis as well as psoriasis, psoriatic arthritis, along with Crohn’s and ulcerative colitis. Its patent life terminated in 2016 in the US [1]. However, in the US AbbVie has stated that, although the composition of matter patent covering Humira expired in December 2016, non-composition of matter patents covering Humira expire no earlier than 2022. The company has therefore made settlement agreements with Amgen and Samsung Bioepis, delaying the launch of biosimilars until January 2023 [2, 3].
Spanish associations sign biosimilars collaboration
The Spanish Association of Biosimilar Medicines (BioSim) announced on 21 March 2018 that BioSim and the Federation of Spanish Medical Scientific Associations (FACME) have signed a collaboration agreement that includes the creation of a joint working group to share up-to-date information on biosimilars.
Life cycle and regulatory evaluation of biosimilars
The life cycle of a biosimilar, like any biological, starts with research and development, then manufacturing, and is followed by regulatory evaluation of quality, safety and efficacy for both licensing and post-licensing oversight. Once licensed, a biosimilar is an individual product and post-licensing evaluation should be carried out like any other biological. The only difference for a biosimilar is that regulatory approval relies on the safety and efficacy data and knowledge gained during the development and licensing of an originator, or reference product.
Etanercept biosimilars submitted to EMA and launched in Japan
An etanercept biosimilar has been submitted to the authorities in Europe and Japan, and another etanercept biosimilar has been launched in Japan.
