Biosimilars

Cost savings from the use of biosimilars in Canada

Analysis of the potential cost savings from the use of three biosimilars (filgrastim, infliximab and insulin glargine) in Canada shows that over CA$1 billion could have been saved in just a two-year period [1].

Denosumab copy biological clinical trial application accepted in China

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted a clinical trial application of denosumab copy biological HLX14.

Celltrion/Teva launch trastuzumab biosimilar Herzuma in US

Celltrion and Teva announced in March 2020 that they have launched their trastuzumab biosimilar Herzuma (trastuzumab-pkrb) in the US. Herzuma can be used to treat breast and gastric cancer and has recently been approved in Canada [1].

Clover starts phase III trial for etanercept copy biological in China

At the end of December 2019, Clover Biopharmaceuticals (Clover), a Chinese company focused on biological therapies, announced the start of a phase III trial of their etanercept copy biological (SCB-808), a proposed copy biological to originator biological Enbrel (etanercept).

US oncologist says Medicare should not practice medicine

Clinical oncologist, Dr Debra Patt, who serves on the US Oncology Research Breast Cancer Committee and chairs the breast cancer subsection of the pathways task force for The US Oncology Network, expresses her opinion on a new policy introduced by Medicare, which she believes is ‘having a negative impact on a patient’s outcome’.

Positive phase I results for Qilu’s bevacizumab copy biological

Positive results were reported from a phase I trial of a bevacizumab copy biological, QL1101, which the authors say is ‘the first study to compare the pharmacokinetics of QL1101, a proposed bevacizumab [copy biological], with Avastin’ [1].

Celltrion launches infliximab biosimilar Remsima SC in Europe

In a successful time for Celltrion Healthcare (Celltrion), the company has launched their infliximab biosimilar Remsima in Germany and the UK.

PK and PD similarity between pegfilgrastim biosimilar and Neulasta

Hexal AG has published phase I results for its approved pegfilgrastim biosimilar [1-3].

FDA and FTC collaborate to deter anti-competitive behaviour for biologicals

The US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) announced on 3 February 2020 that they would enhance their collaboration when it comes to anti-competitive behaviour in the biologicals’ marketplace.

Arguments against Alberta’s plans to switch patients to biosimilars

In May 2019, the Canadian province of British Columbia introduced a policy of switching rheumatology patients to biosimilars [1]. Now, the province of Alberta is also considering plans to stop coverage of originator biologicals and switch patients to biosimilars for certain indications. The new policy, if introduced, will apply to the approximately 30,000 patients in Alberta living with inflammatory bowel disease (IBD) [2].

Amgen starts phase III trial for aflibercept biosimilar

US-based biotech giant Amgen is initiating a phase III clinical trial for a biosimilar of Regeneron’s Eylea (aflibercept).

FDA publishes historic drug approvals and searchable Purple Book

The US Food and Drug Administration (FDA) has released a dataset of drug approvals dating back to 1985 and an online, searchable version of the Purple Book of licensed biologicals.

Tackling the challenge of safe automatic substitution of biologicals

The costs of biologicals are challenging the sustainability of pharmacotherapy. Affordable biosimilars are expected to trigger competition within the biologicals market. Increasing real-world experience on biosimilars and clinical switching studies have led to position papers supporting the interchangeability of biosimilars with their reference products under the supervision of the prescriber [1]. However, the uptake of biosimilars has been poor in Finland, since physicians have been reluctant to prescribe biosimilars, especially in the outpatient setting. One option to stimulate the uptake of biosimilars is the automatic substitution of biologicals at the pharmacy level.

Biosimilars in the age of patient-centricity

In 2020, nearly all pharmaceutical companies claim to be ‘patient-centric’. In fact, some companies have even initiated processes of designing new treatments ‘around the patient’ and convened ‘Patient Advisory Boards’ to ensure patients provide their input into clinical trial design. In addition, though to a lesser extent, some have also developed educational programmes to ensure clinicians and patients truly understand the use and function of biosimilars. Regulators have also participated in the effort to ensure that patients consent to be prescribed biosimilar treatments and are well informed of their relative risks and benefits. President of the French Association of Pharmaceutical Medicine, Dr Francois-Xavier Frapaise, discusses how these latest ‘patient-centric’ efforts affect patients [1].

FDA accepts application for Mylan’s bevacizumab biosimilar

US-based drugmaker Mylan announced on 27 February 2020 that the US Food and Drug Administration (FDA) had accepted its application for its bevacizumab biosimilar (MYL 1402O).

Ontario becomes third Canadian province to switch patients to biosimilars

In Canada, the province of Ontario has followed Alberta and British Columbia in introducing a policy to switch certain patients to biosimilars.

Positive results for Bio-Thera’s bevacizumab copy biological

China-based Bio-Thera Pharmaceuticals (Bio-Thera) announced positive results from a phase III trial of its bevacizumab copy biological.

Reasons and solutions for the high cost of insulin in the US

The most commonly used forms of analogue insulin cost 10 times more in the US than in any other developed country. In fact, the cost of insulin in the country has more than tripled in the past 10 years [1]. This has led to patients rationing their insulin; something that does not happen in other developed countries, but is common in the US.

Bio-Thera launches first adalimumab copy biological in China

Bio-Thera Solutions (Bio-Thera) announced in January 2020 the launch of the first adalimumab copy biological in China. The drug can be used to treat rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis and will be marketed as Qletli.

Mylan launches anti-cancer biosimilar in the US

The US drug market receives a new oncology biosimilar as Mylan launches its trastuzumab biosimilar, Ogivri.

Mylan launches anti-cancer biosimilar in the US

Pfizer launching biosimilars in US and Japan but not in EU

In early 2020, pharma giant Pfizer announced that it was launching its rituximab biosimilar in Japan and that it would be launching three new biosimilars onto the US market.

Relative bioavailability of FKB327 when administered using different methods

FKB327 is a biosimilar of Humira (adalimumab), a recombinant, human immunoglobulin G1 monoclonal antibody specific for human tumour necrosis factor alpha (TNF-α). The European Medicines Agency approved FKB327, as Hulio, in 2018 [1].

Phase III trial started in China for eculizumab copy biological

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) is starting a phase III clinical trial in China for a copy biological of Soliris (eculizumab), made by Alexion Pharmaceuticals (Alexion).

Achieving fairer prices for generics and biosimilars

Access to safe, effective, quality assured, and affordable essential medicines and vaccines for all has been identified as key to achieving universal health coverage and financial protection. However, this is not always the case, according to Alessandra Ferrario and colleagues from the Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Healthcare Institute, Boston, USA [1].

Key issues for adalimumab biosimilars

Adalimumab is a popular and effective antibody treatment for inflammatory bowel disease (IBD). A recent position statement from the Belgian IBD research group (BIRD) reviews key issues surrounding the use of adalimumab biosimilars, including extrapolation, immunogenicity and switching [1].

EMA approval for rituximab biosimilar Ruxience

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 January 2020 that it had recommended granting marketing authorization for the rituximab biosimilar Ruxience.

Failures when switching patients to biosimilar etanercept

A ‘real-world’ study on switching patients from the originator etanercept, Enbrel, to the biosimilar Benepali (SB4) investigated the reasons why some patients switched back to the originator [1].

Rituximab biosimilar ABP 798 submitted to FDA

US-based biotech giant Amgen and its partner Allergan announced on 19 December 2019 that their rituximab biosimilar (ABP 798) had been successfully submitted to the US Food and Drug Administration (FDA) for review.

Law and ethics of switching to biosimilars in Canada

With healthcare budgets in mind, governments and financial institutions across the globe are planning or implementing non-medical or ‘forced’ switches by cutting drug coverage for reference biologicals and funding only less expensive biosimilars. This is a subject fraught with issues related to both the law and the ethics of switching. Authors Blake Murdoch and Timothy Caulfield of the Health Law Institute, Faculty of Law, University of Alberta, Edmonton, Alberta, Canada, try to address how such issues might affect Canada [1].

Biosimilars applications under review by EMA – January 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.

Mabpharm files infliximab copy biological application in China

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 6 January 2020 that its partner, China-based Mabpharm, had filed a marketing application with China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) for its infliximab copy biological (CMAB008).

Adalimumab biosimilars in Europe: a review

A recent position statement from the Belgian inflammatory bowel disease (IBD) research group (BIRD) reviews the five biosimilars of adalimumab available in the European Union (EU) [1]. Adalimumab, which has been marketed under the brand name Humira, is a popular antibody treatment for a number of inflammatory conditions.

China approves bevacizumab copy biological Ankeda

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), announced on 9 December 2019 that it had approved Ankeda, a bevacizumab copy biological.

Swiss position statement on the use of biosimilars in IBD

Experts from the Swiss Society of Gastroenterology have provided a position statement on the use of biosimilars in inflammatory bowel disease (IBD). The position paper summarizes key regulatory and clinical issues around biosimilars to help improve clinician and patient awareness.

Teriparatide biosimilar Terossa approved in South Korea

South Korea-based Daewon Pharmaceutical has obtained regulatory approval to begin marketing and selling its teriparatide biosimilar in Korea.

Eli Lilly and Novo Nordisk launches lower-priced insulin options

Originator insulin makers Eli Lilly and Novo Nordisk have both announced the introduction of additional reduced cost insulin options for patients.

Bevacizumab and teriparatide biosimilars launched in Japan

Biosimilars for osteoporosis treatment teriparatide and for anticancer drug bevacizumab were launched in Japan in late 2019.

Real-life clinical effectiveness of Razumab in wet AMD

The multicentre, retrospective RE-ENACT 2 study evaluated the real-world effectiveness of ranibizumab biosimilar, Razumab, for the treatment of wet age-related macular degeneration (wet AMD). This report presents the results from a subgroup analysis of the RE-ENACT 2 study [1].

WHO prequalifies first biosimilar

The World Health Organization (WHO) has prequalified its first biosimilar – trastuzumab – in a move that the organization says, ‘could make this expensive, life-saving treatment more affordable and available to women globally’.

Samsung Bioepis and AffaMed to start trastuzumab trial in China

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has granted approval for partners Samsung Bioepis and AffaMed Therapeutics (AffaMed) to start a phase III trial for their trastuzumab product, SB3.