Biosimilars

Indications expanded for Merck’s etanercept biosimilar Brenzys

Biosimilars/News | Posted 25/09/2020

The indications of Merck Canada’s etanercept biosimilar Brenzys have been expanded to include plaque psoriasis, psoriatic arthritis and juvenile idiopathic arthritis.

FDA to investigate PD biomarkers to show biosimilarity

Biosimilars/Research | Posted 25/09/2020

The US Food and Drug Administration (US FDA) is conducting research on critical aspects of the use of pharmacodynamic (PD) biomarkers to demonstrate biosimilarity. A study published in Clinical Pharmacology and Therapeutics, has outlined how the agency hopes to inform their thinking on critical aspects of how these biomarkers can be used to reduce the need for comparative clinical studies [1]. In turn, this can reduce the time and cost of bringing a biosimilar product to market, giving faster access to affordable, safe, and effective treatments.

FDA updates Purple Book database

Biosimilars/General | Posted 25/09/2020

The US Food and Drug Administration (FDA) has updated its searchable Purple Book database to include allergenic, cellular and gene therapy, haematologic and vaccine products.

Insulin glargine biosimilar Semglee launched in US

Biosimilars/News | Posted 18/09/2020

The partnership of US-based drugmaker Mylan and Indian biologicals specialist Biocon announced on 31 August 2020 the launch of their insulin glargine product, Semglee, in the US.

Biosimilars allow fast access to biological drug therapy in Bavaria, Germany

Biosimilars/Research | Posted 18/09/2020

A new study has shown that patients suffering from rheumatism in Bavaria, Germany, are now likely to be prescribed a biological medicine much faster than five years ago. Results of the study were shared at the AG Pro Biosimilars digital symposium on 14 September 2020.

What oncologists do not understand about biosimilars

Biosimilars/Research | Posted 18/09/2020

The availability of biosimilars may improve access to health care by increasing the number of therapeutic options available at potentially lower costs. However, based on the results of multiple surveys of many healthcare providers (HCPs) conducted in recent years, clinicians appear wary of prescribing biosimilars.

Country scorecards show biosimilar sustainability

Biosimilars/General | Posted 18/09/2020

Biosimilars are an important component of sustainable health systems as they provide alternatives to originator biological products once those products no longer have market exclusivity. Europe has the world’s largest biosimilar market, accounting for approximately 60% of the global market. European countries therefore serve as valuable examples of successful approaches to biosimilar policy [1]. Nevertheless, across Europe, the level of competition among biosimilars differs widely by country and by molecule, as does the extent of their use and their impact on pricing. Much of this variability can be linked to differences in health system policy elements that contribute to sustainable market conditions for biosimilars.

Budget savings from biosimilar infliximab in the UK, France, Japan and Korea

Biosimilars/Research | Posted 11/09/2020

Biological medicines are attracting attention from policymakers and health insurers across countries due to their increased financial burden. The potential for biosimilars’ cost savings can be influenced by various factors, including supply-side (pricing policies) and demand-side (usage-enhancing) policies.

Samsung Bioepis launches Ontruzant in Brazil

Biosimilars/News | Posted 11/09/2020

South Korean biotechnology company Samsung Bioepis has announced the launch of their trastuzumab biosimilar Ontruzant in Brazil. The product was approved by the Brazilian health agency in May 2019.

Duopharma to establish Malaysia’s first commercial biosimilar facility

Biosimilars/General | Posted 11/09/2020

Malaysia-based manufacturer Duopharma Biotech aims to establish Malaysia’s first commercial biosimilar production facility. The company is also working to achieve halal certification for its erythropoietin biosimilar, Erysaa.

Cadila Pharmaceuticals launches two similar biologics in India

Biosimilars/News | Posted 11/09/2020

Indian generics maker Cadila Pharmaceuticals Ltd (Cadila) has launched two new similar biologics in the country: Bevaro (bevacizumab) and Ritucad (rituximab).

Celltrion’s biosimilars effective against gastric cancer and B-cell lymphoma

Biosimilars/Research | Posted 11/09/2020

Recent clinical trial results confirm that Celltrion’s biosimilars Herzuma (trastuzumab) and Truxima (rituximab) are effective in the treatment of gastric cancer and B-cell lymphoma, respectively.

EC approval for trastuzumab biosimilar Zercepac

Biosimilars/News | Posted 04/09/2020

The European Commission (EC) has granted marketing authorization for the trastuzumab biosimilar Zercepac (HLX02) on 27 July 2020. The product is produced by the Shanghai Henlius Biopharmaceutical Co Ltd (Henlius), making it the first China-made biosimilar to receive approval in Europe.

WHO prequalifies Celltrion’s trastuzumab biosimilar Herzuma

Biosimilars/General | Posted 04/09/2020

The World Health Organization (WHO) has prequalified Celltrion Healthcare’s second biosimilar, a trastuzumab biosimilar sold as Herzuma.

Monoclonal antibody biosimilars and cancer in the EU

Biosimilars/Research | Posted 04/09/2020

Spanish researchers investigated the current status of biosimilar monoclonal antibodies (mAbs) in the European Union (EU) by reviewing the regulatory pathway, the rationale for extrapolation and switching and the current status and future perspectives of the biosimilars approved in the EU [1].

The biosimilars market in Latin America: a summary

Biosimilars/Research | Posted 28/08/2020

A review of the biosimilars market in Latin America [1] finds that Argentina, Brazil and Mexico have the largest number of approved similar biotherapeutic products (SBPs), while information in other countries is more limited. The review recommends investment in biotechnology hubs and further development of regulation on biological drugs.

EMA recommends approval of bevacizumab biosimilar Equidacent

Biosimilars/News | Posted 28/08/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 July 2020 that it had recommended granting of marketing authorization for the bevacizumab biosimilar Equidacent, which is produced by Centus Biotherapeutics, a joint venture between AstraZeneca and Fujifilm Kyowa Kirin Biologics

Clinical trials for trastuzumab biosimilars

Biosimilars/General | Posted 28/08/2020

Roche’s originator trastuzumab biological (Herceptin) was approved by the US Food and Drug Administration (FDA) in September 1998 and by the European Medicines Agency (EMA) in August 2000 [1]. The patents on Herceptin expired in Europe in July 2014 and in the US in June 2019 [1]. This has led to biosimilars of trastuzumab being developed.

Sustainable biosimilar policies in Europe

Biosimilars/Research | Posted 31/07/2020

A review of approaches to biosimilar policy in Europe [1] highlights key principles for a sustainable biosimilar market, including supporting innovation and allowing for multiple suppliers.

EC approval for Sanofi’s insulin aspart biosimilar

Biosimilars/News | Posted 31/07/2020

The European Commission (EC) has issued marketing authorization for Sanofi’s insulin aspart biosimilar, which references Novo Nordisk’s product NovoLog and is used to treat type 1 and 2 diabetes.