Biosimilars

Biosimilars of eculizumab

Last update: 20 October 2017

Eculizumab is a humanized monoclonal antibody that is a terminal complement inhibitor. It is used to treat people with paroxysmal nocturnal haemoglobinuria (PNH), for whom it improves quality of life but does not appear to affect the risk of death. It is also indicated for the treatment of patients with atypical haemolytic uremic syndrome (aHUS) – a disease that primarily affects kidney function – to inhibit complement-mediated thrombotic microangiopathy.

Rituximab biosimilar from Sandoz accepted for review by EMA

Sandoz, the generics division of Novartis, announced on 24 May 2016 that its regulatory submission for its proposed rituximab biosimilar (GP2013) had been accepted by the European Medicines Agency (EMA).

Samsung Bioepis infliximab biosimilar accepted for review by FDA

Samsung Bioepis (a Biogen and Samsung joint venture) and Merck announced on 24 May 2016 that the US Food and Drug Administration (FDA) had accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis for the companies’ infliximab biosimilar candidate, SB2.

Monoclonal antibodies and the challenge of substitution

Healthcare payers are eagerly awaiting the arrival of biosimilar competition in the innovative monoclonal antibody sector in order to drive down drug prices and increase patients’ access to these medicines. As the first to introduce scientific and regulatory requirements for the approval of biosimilars in 2004, the European Union (EU) has emerged as a testing ground for biosimilars. In view of the lack of stance of EU governments and national institutions on substitution for biosimilars, hospitals and healthcare structures logically took up this major issue.

Roche sues India’s drug regulator over Avastin ‘similar biologics’

Switzerland-based drug giant Roche has sued the Drug Controller General of India (DCGI) in the Delhi High Court over ‘similar biologic’ versions of its cancer blockbuster Avastin (bevacizumab).

Pharmacokinetic behaviour of a trastuzumab biocomparables

Biosimilars represent a viable alternative for the treatment of chronic and degenerative diseases of many patients worldwide who cannot afford the costs of biotherapies based on originator products. Trastuzumab is a humanized monoclonal antibody, which is used for the treatment of HER2-positive breast cancer. In the review paper of Miranda-Hernández et al. [1], the authors described the development of a trastuzumab biocomparable by Mexico-based Probiomed. This biocomparable, according to the authors, was developed in compliance with international guidelines and the characterization of Critical Quality Attributes (CQAs), as well as the pharmacokinetic parameters evaluated in healthy volunteers, demonstrated comparability with the reference product.

Switching between different ESAs

Switching between reference biologicals and biosimilars can be a contentious issue. A study from Italy, however, has found that this phenomenon is not limited to reference products and their biosimilars, but also often occurs between originator biologicals and other originator biologicals within the same category [1].

Positive phase III results for omalizumab copy biological

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 16 May 2016 that its partner, MabTech had successfully completed a combined phase II and III clinical trial in China for STI-004, a copy biological for omalizumab (Xolair). STI 004 met its primary endpoint in a multicentre, randomized, double-blind, placebo-controlled, clinical study.

Uptake of biosimilars increasing in Spain

Use of biosimilars in Madrid, Spain, has increased after approaches were introduced to try and improve uptake of biosimilars in the country, according to Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain [1].

Clinical and regulatory issues for biosimilars

As the first biosimilars are being approved in the US, there are a number of clinical and regulatory issues that must be considered for the safe and appropriate utilization of these products within the health system [1]. Biosimilars provide the opportunity to lower cost and improve access to important biological treatments. However, their success will depend largely on their acceptance by clinicians, payers and patients.

Samsung Bioepis to launch infliximab biosimilar in South Korea

Samsung Bioepis has completed the regulatory process to enable the launch of its second biosimilar Renflexis (infliximab) in South Korea.

Japan proving to be a favourable market for biosimilars

Uptake of biosimilars in Japan is on a par with generics use for some products, making Japan a lucrative market for biosimilars makers.

Approaches to increase uptake of biosimilars in Spain

Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain, describe approaches that have been introduced in Spain to try and improve uptake of biosimilars in the country [1].

Benepali wins Danish tender for etanercept

Denmark’s drug procurement agency Amgros has chosen the etanercept biosimilar Benepali, made by Samsung Bioepis, as the priority drug for treating rheumatoid arthritis rather than the originator biological (Amgen’s Enbrel).

A strategic approach to increase uptake of biosimilars in Spain

Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain, describe the strategic approach that has been introduced in Spain to try and improve uptake of biosimilars in the country [1].

Biosimilars applications under review by EMA – April 2016

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.

Improving uptake of biosimilars in Spain

Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain, investigated how efforts to improve the uptake of biosimilars in the country have been working.

Samsung Bioepis starts phase III trial for bevacizumab biosimilar

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis has started a phase III clinical trial for a biosimilar version of Roche’s cancer blockbuster Avastin (bevacizumab).

Biosimilars group launched in UK to improve biosimilars uptake

On 18 April 2016, the British Generic Manufacturers Association (BGMA) announced the launch of its expert sector group on biosimilars, the British Biosimilars Association (BBA).

US rheumatologists in favour of distinct names for biosimilars

Following the approval of the infliximab biosimilar Inflectra (infliximab-dyyb) the American College of Rheumatology (ACR) has issued a statement supporting the use of distinct names for biosimilars.

Biosimilars: the clinical perspective

How biosimilars can be viewed from a clinical perspective was discussed in a review of biosimilars in rheumatology by author José M Serra López-Matencio and colleagues from the Universidad Autónoma, Madrid, Spain*.

New administration route for epoetin alfa biosimilar Binocrit

Sandoz, the generics division of Novartis, announced on 8 April 2016 that the European Commission (EC) has approved a type II variation for the addition of a subcutaneous (SC) route of administration for its epoetin alfa biosimilar Binocrit’s nephrology (kidney function) indication.

A multidisciplinary perspective on biosimilars

A biosimilar is an officially regulated and approved copy of an originator biological therapy. Authors Khraishi et al. aimed to provide a comprehensive review of the biosimilar development process and multidisciplinary guidance on their potential therapeutic utility in clinical practice [1]. They discussed clinical developments in the introduction of biosimilars across the expert disciplines of gastroenterology, nephrology, oncology and rheumatology, and from a payer perspective. They highlight a common need for ongoing pharmacovigilance, robust head-to-head clinical studies, and real-world data to establish the long-term risk-benefit profile of biosimilars.

Biosimilars: management of clinical issues

How to manage clinical issues encountered with biosimilars was a topic discussed in a review of biosimilars in rheumatology by author José M Serra López-Matencio and colleagues from the Universidad Autónoma, Madrid, Spain*.

BioOutsource launches ready-to-use biosimilarity assays

Sartorius Stedim BioOutsource (BioOutsource), a subsidiary of Sartorius Stedim Biotech, has launched a range of ready-to-use assays for testing biosimilarity. The assays are available for biosimilars of Hoffmann–La Roche/Chugai’s rheumatoid arthritis treatment Actemra (tocilizumab), Centocor’s psoriasis treatment Stelara (ustekinumab) and Novartis/Genentech’s age-related macular degeneration drug Lucentis (ranibizumab).

FDA approves infliximab biosimilar Inflectra

The US Food and Drug Administration (FDA) announced on 5 April 2016 that it had approved the country’s second biosimilar Inflectra (infliximab).

EMA recommends approval of infliximab biosimilar Flixabi

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 1 April 2016 that it had recommended granting of marketing authorization for a biosimilar infliximab product (SB2).

Biosimilars of insulin glargine

Last update: 27 November 2020

Insulin glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours. Insulin glargine is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above.

European regulatory pathways for biosimilars

The European regulatory pathways for biosimilars were discussed in a review of biosimilars in rheumatology by author José M Serra López-Matencio and colleagues from the Universidad Autónoma, Madrid, Spain*.

IPRF template for summary information for biosimilar reviews

The Biosimilars Working Group (BWG) of the International Pharmaceutical Regulators Forum (IPRF) has released a template for Public Assessment Summary Information for Biosimilar (PASIB).

How the biosimilars market is changing

Access to high quality medicine at affordable prices without jeopardizing patients’ health is one of the key challenges in developed countries where rising life expectancy and growing average age puts pressure on national healthcare systems. Biosimilars represent a class of medicinal products that seem to be attractive in tackling this challenge. However, market acceptance of biosimilars in general is still low.

Biologicals: characteristics that make them unique and special

The unique characteristics of biologicals were discussed in a review of biosimilars in rheumatology by author José M Serra López-Matencio and colleagues from the Universidad Autónoma, Madrid, Spain*.

Biocon receives Japanese approval for insulin glargine biosimilar

India-based biologicals specialist Biocon announced on 28 March 2016 that it had received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its insulin glargine biosimilar.

IGBA opposes WHO biological qualifier

The World Health Organization (WHO) is considering a proposal to assign Biological Qualifiers (BQs), which are random alphabetic codes, to help standardize the naming of biologicals, including biosimilars [1]. However, not everyone agrees with their proposal.

Biosimilars: a new challenge in the current pharmacology

In a review of biosimilars in rheumatology author José M Serra López-Matencio and colleagues from the Universidad Autónoma, Madrid, Spain discuss issues surrounding biosimilars*.

Epoetin alfa biosimilar effective in treating anaemia

Authors of a post-marketing study of the epoetin alfa biosimilar Retacrit say that the biosimilar is effective and well tolerated in treating chemotherapy-induced anaemia (CIA) [1].

Pharmacovigilance for mAbs

Professor Pierre Michetti, a gastroenterologist at the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland in his paper discusses questions related to monoclonal antibody (mAb) biosimilars [1]. One question addressed was that of pharmacovigilance for mAbs.

US doctors poised to prescribe biosimilars

A survey of specialists in the US has found that nearly half of them expect to prescribe biosimilars to treatment-naïve patients.

Benefits and concerns related to biosimilars

As patents of the first introduced biological therapeutics in oncology have begun to expire, competing pharmaceutical companies are allowed to produce and market the same protein as the originator agent. This follows the pattern of the development of generics. However, biosimilars are fundamentally different from generics. Particularly in the field of oncology, the introduction of monoclonal antibodies has resulted in spectacular therapeutic advances by increasing the cure rate of early cancers and prolonging survival. Similar advances have occurred in rheumatology, haematology, neurology and other fields. Most therapeutic biologicals are monoclonal antibodies with molecular weights of around 140,000 Daltons [1]. Other peptides include hormones, growth factors and vaccines [2]. Most of those products are expensive and their broad application drains the financial resources of healthcare systems. Therefore, the development of biosimilars is expected to be mutually beneficial for both the pharmaceutical industry and society: pharmaceutical companies may enter a lucrative business, whereas payers reasonably expect lower prices for these costly but essential drugs.

Merck Group starts phase III trial for adalimumab biosimilar

Germany’s Merck KGaA (Merck Group) announced on 2 March 2016 that it had started a phase III clinical trial for its adalimumab biosimilar (MSB11022) in patients with chronic plaque psoriasis.

Extrapolation of indications for mAbs

Monoclonal antibody (mAb) biosimilars have recently entered the market, raising questions in the healthcare community. One of the questions discussed by Professor Pierre Michetti, a gastroenterologist at the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, was that of extrapolation of indications for mAbs [1].

Amgen sues Sandoz over etanercept biosimilar

Following the submission of application for approval of its etanercept biosimilar in the US, Sandoz is coming under fire from originator company Amgen.

Epirus starts phase III trial for infliximab biosimilar

US-based biologicals company Epirus Biopharmaceuticals (Epirus) announced on 9 February 2016 that it had started a phase III trial for its infliximab biosimilar (BOW015).

Beyond biosimilarity

The advent of monoclonal antibody (mAb) biosimilars has raised a series of questions in the healthcare community. Just a few of these questions were discussed by Professor Pierre Michetti, a gastroenterologist at the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland [1]. 

Sandoz acquires EEA rights to infliximab biosimilar from Pfizer

Sandoz, the generics division of Novartis, announced on 12 February 2016 that it had acquired the rights for the development and commercialization of Pfizer’s biosimilar infliximab (PF-06438179) in the European Economic Area (EEA), which includes the 28 countries of the European Union (EU), plus Iceland, Liechtenstein and Norway.

FDA releases ‘Overview of Biosimilar Products’

As part of its ongoing mission to educate industry, the public and healthcare professionals about biosimilars, the US Food and Drug Administration (FDA) has released an online educational course for healthcare professionals.

Trastuzumab non-originator biological approved in Russia

Russian biotechnology company Biocad announced on 20 January 2016 that the Russian Ministry of Health had approved the company’s trastuzumab non-originator biological, BCD-022. The drug is a non-originator biological of Roche’s breast cancer blockbuster Herceptin (trastuzumab).

Efficacy and safety of biosimilar infliximab compared to other biologicals in rheumatoid arthritis

In the paper by Baji et al. [1], the authors carried out a meta-analysis to compare the efficacy and safety of biosimilar infliximab and other available biologicals for the treatment of rheumatoid arthritis (RA), namely abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab and tocilizumab. The analysis compared the recommended doses of biological disease-modifying anti-rheumatic drugs (DMARDs) indicated in RA.

Safety concerns limit similar biologics uptake in India

How do concerns about the safety of domestic biologicals limit the uptake of ‘similar biologics’ in India? This is a question that author Malipatil tried to address in his review of similar biologics in India [1].

Differences between biosimilars and reference products

A review of glycosylated biosimilars approved in the European Union (EU) and Japan has highlighted structural variances between biosimilars and their reference products [1].

FDA advisers recommend approval of Celltrion’s infliximab biosimilar

US Food and Drug Administration’s (FDA) advisers have voted to recommend the approval of Celltrion’s biosimilar version of Johnson & Johnson and Merck’s arthritis treatment Remicade (infliximab).

EMA accepts application for pegfilgrastim biosimilar

Sandoz, the generics division of Novartis, announced on 11 February 2016 that its regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the European Medicines Agency (EMA).

Celltrion to use cloud-based technology for its biosimilars trials

On 20 January 2016, Korea-based biopharmaceutical company Celltrion announced that it had adopted Medidata’s Clinical Cloud to provide scalable technology for its biosimilars development programmes. The technologies include electronic data capture and management (Medidata Rave), medical coding (Medidata Coder) and randomization and trial supply management (Medidata Balance).

Pharmacovigilance for biologicals in The Netherlands

Escher is an independent regulatory research platform run by Netherlands-based research enabler TI Pharma. The group recently published a paper in the journal Drug Safety on the traceability of biologicals in clinical practice and adverse drug reaction (ADR) reporting [1]. This paper concludes that in The Netherlands brand names are not routinely recorded in clinical practice and batch numbers are poorly recorded. The findings suggest that the limited traceability of brand names and batch numbers in ADR reports for biologicals may be primarily caused by the shortcomings in the recording and tracing of information in clinical practice.

Launch of partnership for biosimilars education and access

The Biosimilars Forum announced on 1 February 2016 the launch of a new biosimilars education initiative. The ‘Partnership for Biosimilars Education and Access’ will focus on raising awareness and encouraging access to biosimilars in the US.

Kyowa to market Sandoz’s rituximab biosimilar in Japan

Biotech firm Kyowa Hakko Kirin (Kyowa) announced on 25 January 2016 that it had made a deal with Sandoz, the generics division of Novartis, for exclusive marketing rights to Sandoz’s biosimilar rituximab in Japan.

Adalimumab biosimilar meets primary endpoint in pharmacokinetic study

On 21 December 2015, Baxalta, a spinoff company from Baxter International, and US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced positive results from a pharmacokinetic study with their candidate adalimumab biosimilar M923.

Biosimilar etanercept offered at 47% discount in Norway

Samsung Bioepis confirmed on 1 February 2016 that it had won a contract in Norway to supply its newly approved biosimilar etanercept, Benepali, to the country.

Positive phase III results for cetuximab and infliximab copy biologicals

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 11 January 2016 that its partner, MabTech had successfully completed phase III clinical trials in China for STI-001, a copy biological for cetuximab (Erbitux) and STI‑002, a copy biological for infliximab (Remicade). Both STI-001 and STI-002 met their primary endpoints in confirmatory, randomized, controlled, two-part phase III studies.

Lack of health insurance limits access to biologicals in India

One example of a negative driver of the ‘similar biologics’ market in India is the lack of health insurance in the country [1].

Australian approval for infertility biosimilar Bemfola

Switzerland-based Finox Biotech (Finox) announced on 30 November 2015 that it had gained approval from Australia’s drug regulator, the Therapeutic Goods Administration (TGA), for follitropin alfa biosimilar Bemfola.

Prescribing similar biotherapeutic products in Latin America

Prescribing practices vary across different countries in Latin America and reveal gaps in understanding and in the use of distinguishable names for biologicals [1].

Biosimilars applications under review by EMA – December 2015

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.

Partnerships driving similar biologics development in India

With biosimilars grabbing an increasing share of the global biologicals market and with India providing a cheaper place to carry out research and development, more international players are partnering with Indian companies.

Filgrastim follow-on biological approved in Brazil

Brazil’s medicines agency, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), announced on 20 October 2015 that it had approved the follow-on biological medicine Fiprima (filgrastim).

What happened in biosimilars during 2015

The past year has once again been a busy one for the biosimilars industry [1]. The most important milestone achieved during 2015 was the landmark decision made by the US Food and Drug Administration (FDA) on 6 March 2015 to approve Sandoz’s filgrastim biosimilar, Zarxio (filgrastim-sndz), for all five indications of the originator product (Neupogen). FDA is also reviewing applications for epoetin alfa, infliximab, etanercept filgrastim and pegfilgrastim biosimilars.

Domestic biologicals cost less in India

One of the factors increasing the use of similar biologics in India is the fact that domestic biologicals cost much less than the originator brand-name biologicals [1].

Bevacizumab non-originator biological approved in Russia

Russian biotechnology company Biocad announced on 30 November 2015 that the Russian Ministry of Health had approved the company’s bevacizumab non-originator biological drug, BCD-021. The drug is a non-originator biological of Roche’s cancer blockbuster Avastin (bevacizumab).

Barriers to biologicals competition

As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to ‘large molecule’ biologicals. Although biologicals represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by the US Congress in 2010 is unlikely to yield significant cost savings.

EMA accepts application for etanercept biosimilar

Sandoz, the generics division of Novartis, announced on 8 December 2015 that the regulatory submission for its proposed etanercept biosimilar (GP2015) had been accepted by the European Medicines Agency (EMA).

Low costs and less stringent regulatory requirements in India

Dr Nagaraj Malipatil, a clinical pharmacologist, from Bangalore, India in his review of ‘similar biologics’ in India, outlines some of the drivers of the ‘similar biologics’ market in India [1].

FDA approves first follow-on insulin glargine treatment

The US Food and Drug Administration (FDA) announced on 16 December 2015 that it had approved Eli Lilly/Boehringer Ingelheim’s biosimilar version of Sanofi’s Lantus (insulin glargine) diabetes treatment.

Inflectra PBS listing expected to deliver savings in Australia

The infliximab biosimilar Inflectra was approved for listing in Australia’s Pharmaceutical Benefits Scheme (PBS) on 1 December 2015. This is a decision that ‘will deliver immediate savings’ to the Australian Government, according to the Generic and Biosimilar Medicines Association (GBMA), a group that represents generic and biosimilar medicine suppliers in Australia.

Pegfilgrastim biosimilar as safe and effective as Neulasta

Sandoz, the generics division of Novartis, announced on 7 December 2015 positive results from a phase III study of its pegfilgrastim biosimilar (LA-EP2006).

Factors affecting the uptake of ‘similar biologics’ in India

In his review of similar biologics in India, Dr Nagaraj Malipatil, a clinical pharmacologist from Bangalore, attempted to address what are the drivers and the limitations to the ‘similar biologics’ market in India [1].

Korean approval for infliximab biosimilar

Samsung Bioepis and partner Merck announced on 4 December 2015 that Samsung Bioepis had received approval for its infliximab biosimilar Renflexis from the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).

Biosimilar adalimumab application submitted to EMA

Biotech giant Amgen announced on 4 December 2015 that it had submitted an application for marketing approval for its adalimumab biosimilar (ABP 501) to the European Medicines Agency (EMA).

Regulation and uptake of ‘similar biologics’ in India

India has, by far, demonstrated the greatest acceptance of ‘similar biologics’. But what are the drivers and the limitations to the ‘similar biologics’ market in India? This is a question Dr Nagaraj Malipatil, a clinical pharmacologist, from Bangalore, India tried to address in his review of similar biologics in India [1].

Assessing the immunogenicity of monoclonal antibodies

Safety is a major concern when it comes to biologicals (including biosimilars) and the most critical safety concern is immunogenicity. This is especially important in monoclonal antibody (mAb) biologicals, which are large molecules with complex structures and functions and which represent the largest class of biologicals [1].

Positive phase III results for adalimumab biosimilar

US-based biologicals giant Amgen announced on 9 November 2015 that results from a phase III study of its adalimumab biosimilar (ABP 501) had ‘met the primary endpoint’.