Biosimilars
Improving stakeholder understanding about biosimilars
The arrival of biosimilars provides benefits for healthcare systems and patients by lowering treatment costs and improving patient access to biologicals. Despite these benefits and demonstrated comparability with the reference biological, the use of biosimilars varies across regions and remains limited in some cases. This may be partially due to a lack of knowledge and understanding among healthcare professionals and patients about biosimilars, limiting their willingness to use them.
Innovent starts phase II trial for ipilimumab copy biological
China-based Innovent Biologics (Innovent) announced on 11 December 2020 that the first patient had been successfully enrolled and dosed in the randomized, double-blind, phase II multicentre clinical trial (NCT04590599) evaluating its ipilimumab copy biological (IBI310) in combination with TYVYT (sintilimab) for the treatment of patients with second-line or above advanced cervical cancer.
Biosimilar approvals and patent litigation in the US
Authors from Law360 have examined biosimilar approvals by the US Food and Drug Administration (FDA) under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and ensuing patent litigation actions. They also discuss why the lack of new approvals and litigation in 2020 does not suggest reduced interest in biosimilars but signals a new wave of biosimilars on the horizon [1].
Interchangeability, naming and pharmacovigilance of biosimilars
Results of a survey was carried out by the World Health Organization (WHO) revealed that challenges still remain when it comes to the regulatory evaluation of biosimilars [1].
EMA recommends approval of adalimumab biosimilar Yuflyma
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 December 2020 that it had recommended granting of marketing authorization for an adalimumab biosimilar.
Improving the understanding of biosimilars through education
The process of introducing biosimilars into clinical practice is complex and involves many stakeholders. There are different strategies that healthcare systems have adopted to incorporate biosimilars into patient care. Regulators, payers, pharmacists, and physicians need adequate knowledge in order to be effective components of this process. Previous research in the region has shown a high prevalence of lack of understanding and major safety concerns on the use of biosimilars [1].
Canada approves insulin aspart biosimilar Trurapi
Canada’s drug regulator, Health Canada, has approved the insulin aspart biosimilar Trurapi.
Regulatory issues related to quality of biosimilars
The quality of biosimilars was one of the challenges identified from the results of a survey carried out by the World Health Organization (WHO) [1]. The survey, which was carried out in 2019‒2020, revealed that despite the efforts of WHO in helping Member States implement the evaluation principles in the WHO biosimilar guidelines [2] into their regulatory practices, challenges still remain.
China extends indications for adalimumab and bevacizumab copy biologicals
Chinese biopharmaceutical firm Innovent Biologics (Innovent) announced that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has approved new indications for its adalimumab and bevacizumab copy biologicals.
Understanding and minimizing injection-site pain for biologicals
Biologicals have revolutionized treatment across a range of immune and inflammatory-related diseases and have had considerable impact on the health economy. Switching to a biosimilar has proven to be an effective, safe and pharmacoeconomically advantageous strategy for health systems.
