Biosimilars/General

Amgen explains the steps of manufacturing a biosimilar

US-based biotech giant Amgen explains on its websites the steps involved in manufacturing a biosimilar.

EU approves Henlius copy biologicals facility in China

Following European Union (EU) inspections of Shanghai Henlius Biotech, Inc’s Xuhui facility in China, it is likely that the copy biologicals produced at the site will soon be available internationally.

Reimbursement of biosimilars in the US

Barriers to market uptake of biosimilars in the US include biosimilars pricing, legal and promotional wars being waged by originator companies, and the lack of confidence in biosimilars [1, 2].

Amgen on both sides of the biosimilar arena

Amgen has both originator biologicals and also biosimilars in its portfolio, which means the US-based drugmaker can be on both sides of the fence when it comes to biosimilars.

US FDA clears Biocon manufacturing sites in Malaysia and India

There has been successful closure of US Food and Drug Administration (FDA) inspections at Biocon Biologics sites in Malaysia and India. Three manufacturing sites were issued FDA establishment inspection reports (EIRs) in April 2020. The site in Malaysia is set to produce insulin glargine biosimilar, and two sites in Bangalore, India are set to manufacture trastuzumab and pegfilgrastim oncology biosimilars.

Online education for diabetes specialists on biosimilar insulins

An online educational course has been published by Medscape in collaboration with the Association of Diabetes Care & Education Specialist.

New information on biosimilars from Australia and the US

The Generic Biosimilar Medicines Association and the Biologics Prescriber Collaborative have released new information on biosimilars, aimed at physicians and the public, respectively.

FDA releases new information on interchangeable biologicals

The US Food and Drug Administration (FDA) has released new information on its website, clarifying the difference between biosimilars and interchangeable biologicals and says it will make more treatment options available to more people.

Biosimilars highlights: 2019

There were many biosimilars approved in 2019, as well as new clinical trials, research into issues surrounding biosimilar use, and significant regulatory changes [1], as summarized below.

British Columbia releases latest data on biosimilar switches

The latest data on biosimilar switching in British Columbia, Canada shows that 28% of patients with inflammatory bowel disease (IBD) have switched to a biosimilar version of their medication.

Biocure developing five candidate biosimilars

South Korea’s pharmaceutical industry has fast been expanding as a world player. According to the Korea Health Industry Development Institute, the Korean pharmaceutical industry in 2018 represented 1.8% of the world market, i.e. the 13th largest in the world.

Biosimilars and the safe harbor provision

In the US, the safe harbor provision exempts drug development and approval from patent infringement provisions, and courts have interpreted the safe harbor to apply broadly to Food and Drug Administration (FDA) regulated and approved products, including biologicals. However, courts have continued to struggle with the application of the safe harbor to different types of FDA submissions as the regulatory process has become more complex – and largely have continued to expand its scope.

Access to biosimilars in China, the EU and the US

Access to more affordable treatments is the main driver for the approval of biosimilars. But how does this accessibility vary between Europe, the US and China?

The Patients Association publishes new advice on switching to biosimilars

Patient advocacy group in the UK, The Patients Association, has published new information and an animated video about switching to biosimilars.

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’.

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.

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.

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).

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.

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.

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].

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.

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.

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.

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’.

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].

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.

UnitedHealthcare to preferentially cover Amgen’s anticancer biosimilars

The largest insurer in the US, UnitedHealthcare, has announced it will preferentially cover Amgen’s biosimilar cancer treatments from 1 October 2019.

Similar biotherapeutic products approved and marketed in Latin America

Last update: 29 November 2019

Regulation of similar biotherapeutic products in Latin America varies widely among different countries. Although many countries have yet to introduce guidance for biosimilars, Latin America is moving towards increasing standards of regulation for these products [1, 2].

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.

Biosimilars of epoetin alfa

Last update: 4 November 2019

Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technology. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.

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.

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.

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.

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.

Canadian IBD charity updates biosimilar position statement

On 5 September 2019, Crohn’s and Colitis Canada announced that it had updated its position statement on the use of biosimilars for inflammatory bowel disease (IBD). The updated position statement was published after the organization reviewed its position on biosimilars particularly related to non-medical switching policy.

Court rules Amgen’s patents on Enbrel are valid, Sandoz to appeal

After the US District Court of New Jersey ruled in Amgen’s favour on the validity of its patents for arthritis treatment Enbrel, Sandoz says it will appeal the ruling, which prevents the launch of its biosimilar Erlezi.

Momenta drops Humira biosimilar development

Momenta Pharmaceuticals Inc announced its financial results for the second quarter of 2019 on 2 August 2019. In this, they reported that they will stop the development of their Humira (adalimumab). However, they will continue to develop other biosimilar products.

Australia approves three biosimilars in first half of 2019

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) has up until the end of June 2019 approved three biosimilars. The biosimilars approved in the country so far include two trastuzumab biosimilars and an adalimumab biosimilar.

Biosimilars applications under review by EMA – July 2019

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.

South Korea’s Celltrion to sell directly to Australia

In a successful month for Celltrion, the company announces plans to directly sell its anticancer biosimilars in Australia and begins a clinical trial for allergy treatment CT-P39.

NHS England updates its ‘What is a Biosimilar Medicine?’

The National Health Service (NHS) England announced that it had updated its ‘What is a Biosimilar Medicine?’ document in June 2019.

South Korea increases investment in biologicals

Investment in the biotech sector is ramping up in South Korea, with increased state-led support and private sector pledges.

Eli Lilly launches lower-priced insulin lispro

Eli Lilly announced on 22 May 2019 that it had launched the lower-priced authorized biosimilar version of its diabetes treatment Humalog (insulin lispro) in the US.

UnitedHealthcare to prefer brand-name pegfilgrastim

US health insurance provider UnitedHealthcare has announced that it will prefer use of brand-name pegfilgrastim over the biosimilar versions.

Irish hospitals to get incentives to switch patients to biosimilars

Hospitals in Ireland are being offered a Euros 500 incentive for every patient they switch off two expensive biologicals to cheaper biosimilars.

Settlement for Udenyca and win for Zarxio

Amgen has made a settlement with respect to pegfilgrastim biosimilar Udenyca, but has lost its appeal against filgrastim biosimilar Zarxio.

Biocon/Mylan gain global rights to adalimumab biosimilar Hulio

India-based biologicals specialist Biocon and US-based partner Mylan announced on 7 May 2019 that they have gained the global rights to the adalimumab biosimilar Hulio.

Recommendations published by Canadian breast cancer advocacy group

In April 2019, an advocacy group for patients with breast cancer in Canada – the Canadian Breast Cancer Network (CBCN) - published recommendations related to use of biosimilars in a white paper, entitled ‘Breast Cancer & Biosimilars Recommendations on Use, Implementation and Patient Communications’. These recommendations were informed by insights collected from virtual roundtable discussions with patients and medical oncologists. 

Canadian organizations collaborate to improve biosimilar adoption in cancer and inflammatory rheumatic and bowel disease

With a number of biosimilars expected to launch in Canada in 2019 and beyond, Canadian organizations are collaborating to improve biosimilar adoption. Canada lags behind the European Union in terms of approval and uptake of biosimilars [1].

Patient and provider views on biosimilars to treat breast cancer

A Canadian breast cancer advocacy group collected insights from patients and medical oncologists regarding the use of biosimilar treatments.

FDA to hold public meeting on access to affordable insulin

The US Food and Drug Administration (FDA) is seeking input on the challenges and opportunities the agency should consider as it prepares for the submission and review of applications for biosimilar and interchangeable insulin products, as well as about the development process for such products.

Eli Lilly to introduce half-price authorized insulin biosimilar in US

With high drug prices increasingly coming into the spotlight, Eli Lilly has announced that it will introduce a lower-priced authorized biosimilar version of its diabetes treatment Humalog (insulin lispro) in the US.

Biocad advancing its non-originator biologicals in Russia

Russian biotechnology company Biocad has started an eculizumab study and has also registered its non-originator biological (BCD 057) in Russia.

What happened in biosimilars during 2014

Many new developments have taken place in the biosimilars industry in 2014 [1]. One of the most important milestones during 2014 was the news that the US Food and Drug Administration (FDA) had accepted several biosimilars applications, and had even recommended the approval of Sandoz’s filgrastim biosimilar in all five indications of the originator product (Neupogen).

Biosimilars applications under review by EMA – December 2014

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.

Biosimilars of somatropin

Somatropin or human growth hormone (hGH) is a peptide hormone that stimulates growth, cell reproduction and cell regeneration in humans and other animals. It is thus important in human development. It is a type of mitogen which is specific only to certain kinds of cells. Growth hormone is a 191-amino acid, single-chain polypeptide that is synthesized, stored and secreted by somatotropic cells within the lateral wings of the anterior pituitary gland.

Biosimilars of pertuzumab

Pertuzumab is a monoclonal antibody that inhibits the dimerization of human epidermal growth factor receptor 2 (HER2) with other HER receptors, which prevents them from signalling in ways that promote cell growth and proliferation.

Samsung Bioepis invalidates Herceptin patent in Korea

Samsung Bioepis has won a patent invalidation suit against Roche’s Herceptin in Korea.

Celltrion wins biosimilar deals and Duopharma increases focus on biosimilars in SE Asia

Celltrion Healthcare (Celltrion) has won tenders to supply infliximab to Singapore and rituximab to Thailand, while CCM Duopharma Biotech Bhd (CCMD) aims to increase revenue contribution from its biosimilar products from 22% to over 25%.

Pfizer drops five preclinical biosimilar programmes

US pharma giant Pfizer confirmed on 15 January 2019 that it had terminated five of its preclinical biosimilar programmes after looking at the results of the company’s annual investment review.

Green Shield Canada’s biosimilar switch pilot a success

Canadian not-for-profit healthcare benefits specialist, Green Shield Canada (GSC), announced in December 2018 that its biosimilar transition pilot had been successfully completed.

Alteogen wins process patent for aflibercept biosimilar

South Korean biologicals company Alteogen announced on 4 January 2019 that it had been granted a process patent for its method of producing an aflibercept biosimilar, ALT‑L9, referencing Regeneron’s blockbuster drug Eylea (aflibercept). The patent is a novel method for producing the anti-vascular endothelial growth factor (anti-VEGF) fusion protein.

Adalimumab biosimilar Imraldi makes waves in Europe

Korean biosimilars maker Samsung Bioepis has gained more than 60% of the adalimumab market in Germany for its adalimumab biosimilar, Imraldi. But it’s not just Imraldi and not just in Germany, the company’s accumulated sales for three of its biosimilars in Europe reached US$545.2 million in 2018.

Celltrion wins patent suit in Japan over trastuzumab biosimilar

South Korean biotechnology company Celltrion announced on 5 November 2018 that it had won a patent suit in Japan involving its trastuzumab biosimilar, Herzuma (CT‑P6)

Biosimilars makers in Canada to launch patient support programme

Biosimilars Canada, an association representing Canada’s biosimilar makers, announced on 22 November 2018 that it had chosen pharmaceutical service provider Innomar Strategies to be the preferred provider for the association’s Patient Support Program (PSP) platform.

WHO should finalize its BQ guidance

According to authors from the US, the World Health Organization (WHO) should finalize its Biological Qualifier (BQ) guidance. Distinguishable naming will allow quick and accurate tracing of the manufacturer of biologicals, should adverse events occur and improve patient safety by reducing confusion and mishaps. This will ensure that developing nations, including those in the Middle East and North Africa (MENA) region, have access to high quality, affordable medicines [1].

British diabetologists issues position statement on biosimilar insulin

The Association of British Clinical Diabetologists (ABCD) has issued a position statement on the use of biosimilar insulin. The statement summarises information on the advantages and disadvantages of using biosimilar insulins and gives the association’s position on when biosimilar insulins be used [1].

Biosimilars applications under review by EMA – January 2019

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.

Boehringer Ingelheim and Sandoz abandon biosimilars

Boehringer Ingelheim has decided to abandon biosimilars outside the US. While Sandoz has decided not to pursue biosimilar rituximab in the US.

Merck gains US infliximab contract but drops insulin glargine biosimilar

US pharma giant Merck (known as MSD outside the US and Canada) has signed a deal with the US Department of Veterans Affairs (VA) for its infliximab biosimilar, Renflexis. However, it is pulling out of a deal for insulin glargine biosimilar Lusduna.

Originator biologicals and biosimilars under attack in UK and Japan

Originator biologicals makers and biosimilars makers are finding themselves facing litigation in both the UK and Japan.

Comments on FDA’s public meeting on biosimilars

Comments made at the US Food and Drug Administration’s (FDA) recent meeting on biosimilars included a call for interchangeability information in the Purple Book, criticism of FDA’s use of arbitrary suffixes and a request to waive bridging studies for biosimilars.

Biocon’s biosimilars plant gains clearance from FDA

India-based biologicals specialist Biocon has stated that its biosimilars plant has received a clean bill of health, indicating that it is now compliant with US Food and Drug Administration (FDA) manufacturing requirements.

Samsung Bioepis sued over trastuzumab biosimilar but win for Celltrion’s biosimilar Inflectra

Roche’s Genentech has sued Samsung Bioepis regarding its trastuzumab biosimilar, but Celltrion has won its patent battle against Johnson & Johnson (J&J).

Improving understanding of biotherapeutics and biosimilars

Additional information on biosimilars and biotherapeutics have been published in Europe.

Extension of indications and manufacturing approval for biologicals in the US

Filgrastim biosimilar Granix (tbo-filgrastim) has been approved for extended indications and Samsung BioLogics has received approval to manufacture a monoclonal antibody drug product.

FDA guidance sought on false and misleading information on biosimilars

Pharma giant Pfizer has asked the US Food and Drug Administration (FDA) to issue guidance ‘clarifying appropriate sponsor communications about the nature and properties of biosimilars’.

European nurses launch biosimilar switching guide

The European Specialist Nurses Organisations (ESNO) announced on 26 June 2018 the launch of a guide for switching from reference biologicals to biosimilars.

US pharmacies sue J&J for stifling infliximab biosimilars

Two major US pharmacy chains, Walgreen and Kroger, have sued healthcare giant Johnson & Johnson (J&J) in the US District Court Eastern District of Pennsylvania. The pharmacies allege that J&J prevented insurers from covering biosimilars of its blockbuster immunology drug Remicade (infliximab).