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Safety of switching between reference products and biosimilars

The safety of switching a patient under chronic treatment with a reference biological to a biosimilar has been a topic of ongoing debate since the first biosimilar approval in Europe in 2006. The topic sparked further discussion with the arrival of the more complex monoclonal antibody biosimilars. Concerns have been raised that switching between highly similar but non-identical versions of a biological medicine might lead to increased immunogenicity and as such, impact treatment outcomes. The existing stakeholder uncertainty regarding the safety of switching may have been curbing the use of biosimilars in clinical practice and guidance to support healthcare professionals with clinical decision-making is needed.

Hepatobiliary events similar for SB4 and Enbrel in IJD

According to a study carried out by researchers from Denmark, hepatobiliary adverse events occur at a similar frequency in patients treated with the etanercept biosimilar Benepali (SB4) compared to the originator product, Enbrel, in inflammatory joint disease (IJD) [1].

Do patent strategies delay market entry of biosimilar monoclonal antibodies in Europe?

Patents have been shown to be the main determinant to guarantee market exclusivity of originator biologicals [1], with patent disputes causing uncertainty on a patent’s validity and subsequently potentially influencing launch dates of competitor products, such as biosimilars [2]. In addition, the launch date of a biosimilar might be affected by strategies for prolongation of exclusivity rights on the originator product, such as filing additional patents for a new formulation, new indication or new dosage regime [3].

Scientific evidence in development of trastuzumab biosimilar ABP 980

ABP 980 (Kanjinti) is a biosimilar to trastuzumab reference product (RP) (Herceptin), a monoclonal antibody directed against human epidermal growth factor receptor 2 (HER2). A biosimilar is highly similar to a licensed biological with no clinically meaningful differences in safety, purity and potency [1, 2]. Kanjinti is approved in the US, European Union, and as trastuzumab BS [trastuzumab biosimilar 2] in Japan for all Herceptin indications, which include treatment of HER2 positive (HER2+) metastatic breast cancer, early breast cancer (EBC), and metastatic gastric cancer [3-5]. Development and approval were based on a totality of evidence (TOE) approach, involving stepwise generation of comparative analytical (structural and functional), preclinical, and clinical (pharmacokinetics [PK], pharmacodynamics [PD], efficacy, safety and immunogenicity) evidence [6].

Biosimilar education gaps in oncology

A survey administered by the International Society of Oncology Pharmacy Practitioners (ISOPP) identifies key educational needs on biosimilars amongst its practitioners, including how to compare a biosimilar to an originator and how to manage switching [1].

Non-innovator biologicals in India: regulatory context and areas for improvement

There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal.

Clinical trials for adalimumab biosimilar SB5

The clinical trials used to support the approval of Samsung Bioepis/Merck’s adalimumab biosimilar SB5 (Imraldi/Hadlima), were critically reviewed by authors from Argentina and the UK, with a special focus on rheumatoid arthritis (RA) [1].

Clinical trials for adalimumab biosimilar BI 695501

The clinical trials, especially those in rheumatoid arthritis, used to support the approval of Boehringer Ingelheim’s BI 695501 (Cyltezo), were critically reviewed by authors from Argentina and the UK [1].

Clinical trials for adalimumab biosimilar ABP 501

The clinical trials used to support the approval of Amgen’s ABP 501 (Amjevita/Amgevita/
Solymbic) were critically reviewed by authors from Argentina and the UK [1].

Clinical trials supporting the approval of adalimumab biosimilars

Authors from Argentina and the UK critically review the evidence from trials of biosimilars in rheumatoid arthritis (RA) [1].