Biosimilars

Candidate trastuzumab biosimilar AryoTrust

Biosimilars/Research | Posted 08/10/2021

Biologicals are one of the interesting and effective treatment options which can save the lives of many patients, however, their high cost and restricted access for some patients remains a challenge. The emergence of biosimilars, with their similar efficacy and safety profiles, could be a solution for this hurdle. According to the European Medicines Agency (EMA) guidance entitled ‘Biosimilars in the EU – information guide for healthcare professionals’, a biosimilar is ‘a biological medicine highly similar to another biological medicine already approved in the EU’ [1]. Biosimilars are required to have the same standards of pharmaceutical quality, safety and efficacy as for originator biologicals in order to obtain marketing authorization. Although, according to the EMA guidance ‘approval of biosimilars builds on existing scientific knowledge on safety and efficacy of the reference medicine gained during its clinical use, so fewer clinical data are needed’ [2].

Biosimilars approved in Cuba

Biosimilars/General | Posted 08/10/2021

In Cuba, the regulatory body responsible for approving biological drugs is the Center for the State Control of Medicines, Medical Equipments and Devices (Control Estatal de Medicamentos, Equipos y Dispositivos Médicos, CECMED).

China approving more copy biologicals since new guidelines introduced

Biosimilars/General | Posted 08/10/2021

China has approved many more copy biologicals in the last three years. A move which, according to Pharmaceutical Technology, is thought could be due to the introduction of new guidelines for the products.

Barriers to biosimilar prescribing incentives in Spain

Biosimilars/Research | Posted 08/10/2021

Incentives contribute to the proper functioning of the broader contracts that regulate the relationships between healthcare systems and professionals. Likewise, incentives are an important element of clinical governance understood as healthcare services’ management at the micro-level, aimed at achieving better health outcomes for patients.

Canada’s biosimilar substitution policy: effects on competition and patient safety

Biosimilars/Research | Posted 01/10/2021

A critical review of Canada’s biosimilar substitution policy [1] finds that the scheme has focused on economic factors over other elements such as therapeutic efficacy and market competition. The authors suggest that Canada could learn from the European market, where switching policies retain choice for physicians and patients and promote competition.

Biosimilars approved in Peru

Biosimilars/General | Posted 01/10/2021

In Peru, the regulatory body responsible for approving biological drugs is the General Directorate of Medicines, Supplies and Drugs (DIGEMID) of the Peruvian Ministry of Health (MINSA) which is in charge of leading the National and Decentralised Health System, the policy for the universal health assurance and the policies and intersectoral actions on social determinants [1].

EMA recommends approval of two adalimumab biosimilars

Biosimilars/News | Posted 01/10/2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 17 September 2021 that it had recommended granting marketing authorization for the adalimumab biosimilars Hukyndra and Libmyris.

New Zealand to expand access to rituximab, possibly adalimumab

Biosimilars/General | Posted 01/10/2021

New Zealand’s Pharmaceutical Management Agency, Pharmac, has announced a decision to expand access to rituximab and has launched a proposal to expand access to adalimumab.

Multiple successive switches between infliximab biosimilars in IBD

Biosimilars/Research | Posted 01/10/2021

Recently, biosimilar tumour necrosis factor (TNF) antagonists have become available and are being increasingly used in treating inflammatory bowel diseases (IBD), Crohn’s disease (CD) and ulcerative colitis (UC). The first infliximab biosimilar to receive approval was CT-P13 (Remsima) based on data from rheumatoid arthritis and ankylosing spondylitis, followed by extrapolation to other indications of originator infliximab (Remicade). The second infliximab biosimilar, SB2 (Flixabi), received authorization based on a pharmacokinetic study in healthy volunteers and a study in rheumatoid arthritis [1].

Federal purchases of biological drugs for cancer in Brazil

Biosimilars/Research | Posted 24/09/2021

Buying biosimilars is generally considered to be a way to increase access to cancer treatments in public health services. In Europe, the approval, commercialization and use of similar biotherapeutic products (SBPs) have been encouraged as a way to reduce costs and expand treatment coverage [1, 2]. In Brazil, an analysis of the profile of purchases of monoclonal antibodies (mAbs) acquired by the Unified Health System (SUS) between 2015 and 2019 showed that this premise might not be true in Brazil [2].