Biosimilars

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.

Biocad announces positive rituximab results and plans to enter EU market

Russian biotechnology company Biocad has announced plans to enter the European market and has published positive results for its rituximab non-originator biological Acellbia (BCD-020).

Positive trial results for Lannett’s insulin biosimilar

US firm Lannett has completed a successful trial of their candidate insulin biosimilar, which was compared to Sanofi’s blockbuster insulin product Lantus.

NeuClone progress with ustekinumab and trastuzumab biosimilars

Australian biosimilars firm NeuClone has started a phase I trial of their proposed ustekinumab biosimilar and announced positive results from a trial of their trastuzumab biosimilar.

Non-originator biologicals approved in Russia

Last update: 10 January 2020

In Russia, the regulatory body for the approval of medicines is Russia’s Ministry of Health (Министерство здравоохранения Российской Федерации; Rosminzdrav, Minzdrav).

Analytical similarity assessment of teriparatide biosimilar Terrosa

Terrosa and Movymia (both developed under the code name RGB-10), were the first biosimilars of Eli Lilly’s osteoporosis biological Forteo/Forsteo (teriparatide) in Europe. Gedeon Richter and Stada Arzneimittel gained European Commission approval for Terrosa and Movymia in January 2017 [1] and launched the biosimilars in August 2019 [2]. Meanwhile, RGB-10 was also approved in other countries, including Switzerland and Japan.

FDA approval for Amgen’s infliximab biosimilar Avsola

US-based biotech giant Amgen announced on 6 December 2019 that it had received approval from the US Food and Drug Administration (FDA) for its infliximab biosimilar Avsola (ABP 710).

Canadian gastroenterologists issue biosimilar position statement

The Canadian Association of Gastroenterology (CAG) and Crohn’s and Colitis Canada announced on 24 October 2019 that they had issued a joint position statement on the use of biosimilars for the treatment of inflammatory bowel disease (IBD) [1].

Bio-Thera gains Chinese approval for adalimumab copy biological and starts ustekinumab trial

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has approved Qletli, an adalimumab copy biological. The NMPA has also approved the Investigational New Drug (IND) application from Bio-Thera Solutions (Bio-Thera) to initiate a phase I clinical study for the proposed ustekinumab copy biological BAT2206.

Pharmacists must be ready to take the lead on biosimilars

Pharmacists should take the lead in increasing the adoption of biosimilars in clinical practice, says a review of the implications of biosimilars for pharmacy practice. The review suggests that pharmacists in all settings can take a key role in advocating for biosimilars [1].

Australia approves five biosimilars since June 2019

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) has approved five biosimilars since June 2019. The biosimilars approved in the country since then include three pegfilgrastim biosimilars, a trastuzumab biosimilar and a bevacizumab biosimilar.

Use of pegfilgrastim copy biological Mecapegfilgrastim in neutropenia

Italian oncologists report on studies carried out with a new pegfilgrastim copy biological, Mecapegfilgrastim (HHPG-19K) [1].

Phase III trials started for bevacizumab and natalizumab biosimilars

Phase III trials have started for proposed biosimilars of bevacizumab and natalizumab.

EC approval for subcutaneous infliximab biosimilar Remsima SC

South Korean biotechnology company Celltrion Healthcare (Celltrion) announced on 26 November 2019 that it had received European Commission (EC) approval for the subcutaneous (SC) formulation of its infliximab biosimilar (CT-P13) in patients with rheumatoid arthritis (RA).

WHO launches insulin prequalification programme

The World Health Organization (WHO) has announced a pilot prequalification scheme to certify biosimilar versions of insulin in order to increase supply in low- and middle-income countries.

Biosimilar education for Canadian nurses

In general, Canadian nurses are familiar with biosimilars. However, according to authors Sehdev et al., they may have knowledge gaps in their specific understanding, resulting in a significant unmet need for education.

Lupin to launch etanercept and pegfilgrastim biosimilars in the US

India-based generics maker Lupin, which is expecting European approval for its etanercept biosimilar in March 2020, has announced plans to launch the drug on the US market soon after, alongside a pegfilgrastim biosimilar.

FDA approves adalimumab biosimilar Abrilada

US-based pharma giant Pfizer announced on 18 November 2019 that it had received approval from the US Food and Drug Administration (FDA) for its adalimumab biosimilar (PF 06410293).

Qilu starts phase III trial for denosumab copy biological

Chinese pharmaceutical company, Qilu Pharmaceutical (Qilu) is carrying out a phase III clinical trial for a copy biological of Amgen’s Prolia/Xgeva (denosumab).

Brazilian efficacy and safety data for biosimilar infliximab CT-P13 in the treatment of psoriasis and psoriatic arthritis

Celltrion/Hospira’s infliximab biosimilar Remsima/Inflectra (CT-P13) was authorized by the European Medicines Agency (EMA) in 2013 [1] and by the US Food and Drug Administration (FDA) in 2016 [2].

Biologicals and biosimilar use in Asian patients with IBD

The increasing incidence of inflammatory bowel diseases (IBD) has become a major challenge for gastroenterologists in some Asian countries, particularly China, Japan and Korea. This subject was discussed in the August 2019 issue of the Journal of Gastroenterology and Hepatology [1].

Adalimumab copy biological accepted for review in China

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for the approval of adalimumab copy biological UBP1211.

Oncology pharmacists issue position statement on biosimilars

On 4 October 2019, the International Society of Oncology Pharmacy Practitioners (ISOPP) issued their global position on the use of biosimilars in cancer treatment and supportive care.

Phase I trials started for aflibercept and ustekinumab biosimilars

Phase I trials have started for proposed biosimilars of aflibercept and ustekinumab.

South Korean biologicals company Alteogen has, according to clinicaltrials.gov, started a phase I trial for its candidate aflibercept biosimilar ALT-L9.

Samsung reveals positive trial results for bevacizumab biosimilar, but admits to failure with rituximab

A phase III trial of Samsung Bioepis’ bevacizumab biosimilar has shown equivalence to reference drug Avastin (bevacizumab). However, the company has admitted to failures in its attempt to develop a rituximab biosimilar at a recent trial in the Seoul Central District Court.

FDA approves pegfilgrastim biosimilar Ziextenzo

Sandoz, the generics division of Novartis, announced on 5 November 2019 that it had received approval from the US Food and Drug Administration (FDA) for its pegfilgrastim biosimilar Ziextenzo (LA-EP2006).

Clinical data requirements for biosimilars in the EU: immunogenicity comparability

The totality of evidence approach for biosimilars in the European Union (EU) was discussed in a review paper [1] using case studies to illustrate biosimilars for which differences were observed in different parts of the comparability exercise and the justification for why these differences did not preclude regulatory approval.

Tanvex BioPharma’s filgrastim biosimilar comes under fire

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) is having a rough time lately. In July 2019, Amgen filed an infringement lawsuit against the company regarding its filgrastim biosimilar, TX01. Then in September 2019, US Food and Drug Administration (FDA) rejected Tanvex’s application for approval of TX01.

Biosimilars regulation in Canada: state of play

A paper recently published in GaBI Journal provides an update on the regulation and reimbursement of biosimilars in Canada, including changes to the regulation on switching and processes for private plan reimbursement [1].

Clinical data requirements for biosimilars in the EU: efficacy comparability

The European Medicines Agency (EMA) uses a totality of evidence approach in its regulatory review process for biosimilar approval. As part of this, the biosimilar should demonstrate that it does not have clinically meaningful differences from the originator biological, based on comparative clinical studies.

Bevacizumab ‘similar biologic’ Versavo launched in India

India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 19 August 2019 that it had launched its bevacizumab ‘similar biologic’, Versavo (DRZ_BZ) in India.

Clinical data requirements for biosimilars in the EU: PK and PD comparability

In their article [1], authors from the Paul-Ehrlich-Institut, the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), discussed the totality of evidence approach for biosimilars in the European Union (EU) using case studies to illustrate biosimilars for which differences were observed in different parts of the comparability exercise and on the justification for why these differences did not preclude regulatory approval.

EMA approval for Pegfilgrastim Mundipharma

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 18 October 2019 that it had recommended granting of a marketing authorization for the pegfilgrastim biosimilar Pegfilgrastim Mundipharma.

Positive real-world data for etanercept biosimilar Benepali

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 9 October 2019 that it had presented positive real-world data from its etanercept biosimilar Benepali at the 2019 European Academy of Dermatology and Venereology (EADV) Congress [1].

Clinical data requirements for biosimilars in the EU: analytical comparability

For biosimilars, the regulatory review process is based on the totality of evidence generated in support of biosimilarity.

Russian approval for non-originator dornase alfa

Russian biotechnology company Generium and Swiss-based cell-line producer Selexis announced on 17 September 2019 that the Russian Ministry of Health had approved their dornase alfa non-originator biological drug, Tigerase. The drug is a non-originator biological of Roche’s Pulmozyme (dornase alfa).

Celltrion and Juno make biosimilars deal in Australia and Herzuma launches in Iraq

South Korean biotechnology company Celltrion Healthcare (Celltrion) has entered into a partnership with Juno Pharmaceuticals (Juno) to market the trastuzumab biosimilar Herzuma and rituximab biosimilar Truxima in Australia. The company also launched Herzuma in Iraq.

Trial of bevacizumab copy biological with novel antibody targeting PD-1

China-based Shanghai Henlius Biotech (Henlius) is recruiting patients for a study that will investigate a proposed bevacizumab copy biological in combination with a novel antibody targeting PD-1.

Clinical data requirements for biosimilars in the EU

In their article [1], authors from the Paul-Ehrlich-Institut, the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) discussed the clinical data requirements for biosimilars in the European Union (EU).

FDA approves Pfenex’s follow-on teriparatide product

US-based biotech firm Pfenex announced on 7 October 2019 that it had received approval from the US Food and Drug Administration (FDA) for its follow-on teriparatide product (PF708).

Biocon/Mylan launch first insulin glargine biosimilar in Australia

India-based biologicals specialist Biocon and US-based partner Mylan announced on 3 October 2019 the launch of the first insulin glargine biosimilar in Australia available on the Pharmaceutical Benefits Scheme (PBS).

FDA releases new patient guidance on biosimilars

The US Food and Drug Administration (FDA) has released new patient materials on biosimilars, which explain that biosimilars are as safe and effective as their reference biological and answer a number of commonly asked questions.

Adalimumab copy biological shown to be safe and effective

Chinese biopharmaceutical firm Innovent Biologics’ adalimumab copy biological has shown comparable safety and efficacy to the originator drug, Humira (adalimumab), in patients with ankylosing spondylitis.

Biosimilars applications reviewed in the EU

The European Union (EU) was the first to establish a legal framework for biosimilars back in 2003 [1]. Since the European Medicines Agency (EMA) approved its first biosimilars in 2006, the agency has issued new guidelines and updated its existing guidelines based on new evidence and rapid advances in analytical sciences [2].

Three darbepoetin alfa biosimilars approved in Japan

Three pharmaceutical companies have announced approval of their anaemia treatments for sale on the Japanese market, while Mochida reveals it will sell the first teriparatide biosimilar in the country.

Novo Nordisk to launch biosimilar insulin in the US

Novo Nordisk has announced plans to launch biosimilar versions of its NovoLog and NovoLog Mix insulin products in the US in January 2020.

iBio and CC-Pharming collaborate for rituximab copy biological in China

Biotechnology company iBio, self-professed leader in the plant-made pharmaceutical field, announced on 27 August 2019 that it will expand its collaboration with China-based CC-Pharming for a rituximab copy biological in China.

Switching from originator to biosimilar epoetins appears to be effective and safe

Switching between biological drugs during pharmacological treatment leads prescribers and patients to ask themselves the question: ‘Will it be safe?’. In particular, when switching from an originator to a biosimilar, the belief that this choice is shaped by economic reasons feeds suspicions and controversies.

Positive EMA-CHMP opinion for SC infliximab biosimilar

South Korean biotechnology company Celltrion announced on 22 September 2019 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended for approval the company’s subcutaneous (SC) formulation of its infliximab biosimilar (CT-P13) in patients with rheumatoid arthritis (RA).

Mylan’s insulin biosimilar blocked, but wins patent battle over pegfilgrastim biosimilar

Mylan has received a second complete response letter (CRL) from the US Food and Drug Administration (FDA) over its Lantus biosimilar, while a US District Court rules in their favour over their pegfilgrastim biosimilar, Fulphila.