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.

Biosimilar infliximab reduces medication costs by two thirds in Finland

Biosimilars/Research | Posted 31/07/2020

A study of 54 people with inflammatory bowel disease (IBD) in Finland showed that switching to biosimilar infliximab has no significant impact on health-related quality of life or disease activity, while reducing costs by two thirds [1].

Trastuzumab biosimilar Kanjinti is stable over extended storage periods

Biosimilars/Research | Posted 24/07/2020

An investigation of the quality and in-use stability of diluted trastuzumab biosimilar Kanjinti (also known as ABP 980) versus the reference trastuzumab demonstrated no clinically meaningful differences in stability and activity over extended storage periods, according to Crampton et al. [1].

EMA approves bevacizumab and teriparatide biosimilars

Biosimilars/News | Posted 24/07/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 26 June 2020 that it had recommended granting marketing authorization for the bevacizumab biosimilar Aybintio and for the teriparatide biosimilars Livogiva and Qutavina.

FDA approves pegfilgrastim biosimilar Nyvepria

Biosimilars/News | Posted 24/07/2020

Pharma giant Pfizer announced on 11 June 2020 that it had received approval from the US Food and Drug Administration (FDA) for its pegfilgrastim biosimilar Nyvepria (HSP-130).

Biosimilar pipelines for Korean firms looking healthy

Biosimilars/General | Posted 24/07/2020

Korean companies are becoming more and important both in the country but also worldwide when it comes to developing biosimilars.

FDA approves Mylan’s adalimumab biosimilar Hulio

Biosimilars/News | Posted 17/07/2020

The US Food and Drug Administration (FDA) has approved Mylan/Fujifilm’s adalimumab biosimilar Hulio (adalimumab-fkjp) on 7 July 2020. The product is the sixth adalimumab biosimilar to be approved by FDA and is manufactured by Japan-based Fujifilm Kyowa Kirin Biologics.

Quotas improve biosimilar use in Germany

Biosimilars/Research | Posted 17/07/2020

An assessment of the role of cost control measures on biological drugs in Germany finds that quotas for biosimilars are in some cases associated with increased use and are overall more effective than priority prescribing [1].

New Zealand IBD charity releases position statement on biosimilars

Biosimilars/General | Posted 17/07/2020

The charity Crohn’s and Colitis New Zealand has released a position statement on biosimilars, although there are not yet any biosimilars for inflammatory bowel disease (IBD) on the market in New Zealand.

Celltrion launches Truxima in Brazil

Biosimilars/News | Posted 17/07/2020

On 27 May 2020, South Korean biotechnology company Celltrion Healthcare (Celltrion) announced that it had launched its rituximab similar biotherapeutic product Truxima (CT‑P10) in Brazil.

Biosimilars applications under review by EMA – July 2020

Biosimilars/General | Posted 10/07/2020

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Canada approves infliximab and filgrastim biosimilars Avsola and Nivestym

Biosimilars/News | Posted 10/07/2020

Canada’s drug regulator, Health Canada, has approved the infliximab and filgrastim biosimilars Avsola (ABP 710) and Nivestym.

Denmark achieves 83% reduction in adalimumab costs through switching

Biosimilars/Research | Posted 10/07/2020

Spending on adalimumab in Denmark decreased by almost 83% between September and December 2018, thanks to a mandatory switching policy.

Revance and Mylan move forward with Botox biosimilar

Biosimilars/News | Posted 10/07/2020

US firm Revance Therapeutics (Revance) announced on 1 June 2020 that its partner, US-based drugmaker Mylan, had decided to move forward with a development plan, under a 351(k) pathway, for a proposed biosimilar to Allergan’s cosmetic blockbuster Botox and Botox Cosmetic (onabotulinumtoxinA).

Japanese approval for first adalimumab biosimilar

Biosimilars/News | Posted 03/07/2020

Japan-based Fujifilm Kyowa Kirin Biologics announced on 29 June 2020 that it had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its adalimumab biosimilar FKB327 in Japan.

Biosimilars in Belgium: increasing competition

Biosimilars/Research | Posted 03/07/2020

Competition following the entry of biosimilars is still limited in Belgium, which is mirrored in low biosimilar market shares. Although (short-term) cost savings are realized by the implementation of mandatory price reductions on originator medicines (and obtaining high biosimilar market shares should thus not be a goal in itself), biosimilars can play a key role in ensuring the long-term sustainability of the Belgian off-patent biologicals market.

Positive phase I results for Innovent’s ipilimumab copy biological

Biosimilars/Research | Posted 03/07/2020

China-based Innovent Biologics (Innovent) announced on 3 June 2020 positive phase I results for its candidate ipilimumab copy biological, IBI310.

EC approval for etanercept biosimilar Nepexto

Biosimilars/News | Posted 03/07/2020

The European Commission (EC) has granted marketing authorization for the etanercept biosimilar Nepexto (YLB113), developed by US-based drugmaker Mylan and its partner India-based generics maker Lupin.

China approves bevacizumab copy biological Byvasda

Biosimilars/News | Posted 26/06/2020

China-based drugmaker Innovent Biologics (Innovent) announced on 19 June 2020 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had approved Byvasda (IBI-305), a bevacizumab copy biological.

Successfully transitioning patients with IBD to biosimilars

Biosimilars/Research | Posted 26/06/2020

Pharmacists and physicians from the Boston Medical Center describe the successful transition of patients with inflammatory bowel disease (IBD) using the originator infliximab biological, Remicade, to the infliximab biosimilar, Inflectra (infliximab-dyyb) [1].

Canada approves pegfilgrastim biosimilar Ziextenzo

Biosimilars/News | Posted 26/06/2020

Canada’s drug regulator, Health Canada, has approved the pegfilgrastim biosimilar Ziextenzo (LA-EP2006). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.