Biosimilars

Potential biotech collaboration between India and Colombia

Biosimilars/General | Posted 15/10/2021

A letter of intent on cooperation in biotechnology has been signed between India and Colombia, which could include collaborations on vaccines, biosimilars, and medical devices.

Biosimilars approved in Paraguay

Biosimilars/General | Posted 15/10/2021

In Paraguay, the regulatory body responsible for the approval of biological drugs is the National Directorate for Sanitary Surveillance (Dirección Nacional de Vigilancia Sanitaria, DINAVISA).

Positive trial results for bevacizumab copies from Betta Pharmaceuticals and Biocad

Biosimilars/Research | Posted 15/10/2021

The bevacizumab copy biological MIL60 (Betta Pharmaceuticals Ltd) and non-originator biological BCD-021 (Biocad) have demonstrated clinical equivalence for the treatment of non-squamous non-small cell lung cancer (NSCLC) in phase III trials.

CuraTeQ submits application to EMA for pegfilgrastim biosimilar

Biosimilars/News | Posted 08/10/2021

India-based generics maker Aurobindo Pharma (Aurobindo) announced on 22 September 2021 that its subsidiary CuraTeQ Biologics (CuraTeQ) had submitted an application to the European Medicines Agency (EMA) for its pegfilgrastim biosimilar, BP14.

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].

EC and FDA approval for first ranibizumab biosimilar Byooviz

Biosimilars/News | Posted 24/09/2021

On 18 August 2021, the ranibizumab biosimilar Byooviz (SB11), produced by Samsung Bioepis and commercialized by Biogen, received European Commission (EC) approval. Then on 20 September 2021 the pair announced that Byooviz had also received approval from the US Food and Drug Administration (FDA). This is the first ranibizumab biosimilar, or indeed ophthalmology biosimilar, to receive approval in either Europe or the US.

Biosimilars approved in Uruguay

Biosimilars/General | Posted 24/09/2021

In Uruguay, the regulatory body responsible for the approval of biologicals is the Ministry of Public Health of Uruguay (Ministerio de Salud Pública de Uruguay, MSP).

Long-term safety and efficacy of anti-TNF-α biosimilars in psoriasis

Biosimilars/Research | Posted 24/09/2021

Biologicals have greatly improved treatment options and outcomes for patients with moderate-to severe psoriasis. Despite being significantly more effective than conventional systemic agents for psoriasis, the high cost of biologicals may limit their use [1].

Bevacizumab biosimilars launched in Spain and Korea

Biosimilars/News | Posted 17/09/2021

New bevacizumab biosimilars have been launched in Spain and South Korea.

Off-patent biologicals/Biomimics approved in Bolivia

Biosimilars/General | Posted 17/09/2021

In Bolivia, the regulatory body for the approval of biologicals is the State Agency for Medicines and Health Technologies AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud).

Clinical pharmacists have a critical role in increasing biosimilar uptake

Biosimilars/Research | Posted 17/09/2021

The increasing global burden of chronic diseases, including cancers, diabetes, autoimmune disorders, anaemia of chronic renal failure, rheumatoid arthritis, multiple sclerosis, blood disorders and others, underscore the importance of patients’ access to safe and effective treatments. Interestingly, the introduction of biologicals in the 1980s revolutionized the treatment of these chronic diseases with better prognosis, although high costs and limited patient access remain challenges. These biologicals are known by various names, including biopharmaceutical agents, biologicals, biological therapies, biological agents and biological response modifier therapy or immunotherapy. Biologicals are derived or manufactured from a living biological system. With the majority of originator biologicals losing patent protection and the emergence of biosimilars, the landscape of biologicals is facing many changes.