Biosimilars

Canada approves infliximab biosimilar Remsima SC

Biosimilars/News | Posted 19/02/2021

Canada’s drug regulator, Health Canada, has approved the infliximab biosimilar Remsima SC for the treatment of autoimmune diseases.

Improving stakeholder understanding about biosimilars

Biosimilars/Research | Posted 19/02/2021

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

Biosimilars/News | Posted 19/02/2021

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

Biosimilars/General | Posted 19/02/2021

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

Biosimilars/Research | Posted 12/02/2021

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

Biosimilars/News | Posted 12/02/2021

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

Biosimilars/Research | Posted 12/02/2021

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

Biosimilars/News | Posted 12/02/2021

Canada’s drug regulator, Health Canada, has approved the insulin aspart biosimilar Trurapi.

Regulatory issues related to quality of biosimilars

Biosimilars/Research | Posted 05/02/2021

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

Biosimilars/News | Posted 05/02/2021

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.