Biosimilars/General

Advances for biotech in Korea: Samsung Bioepis, Celltrion and LG Chem

Korean companies Samsung Bioepis and Celltrion have accelerated their penetration into the global market, with a total of 11 approvals in Europe and eight in the US. In addition, Korea’s LG Chem has expanded its presence in Japan and China. This growth follows increasing investment in the biotech sector from South Korea’s government and private pharmaceutical companies [1, 2]. 

Biosimilars approved in Chile

In Chile, the regulatory body responsible for the approval of biological medicines is the National Drug Agency (Agencia Nacional de Medicamentos, ANAMED), which is part of the Institute of Public Health of Chile (ISP), under the Ministry of Health.

Biosimilars approved in Paraguay

In Paraguay, the regulatory body responsible for the approval of biological drugs is the National Directorate for Sanitary Surveillance (Dirección Nacional de Vigilancia Sanitaria, DINAVISA).

Biosimilars approved in Cuba

In Cuba, the regulatory body responsible for approving biological drugs is the Center for the State Control of Medicines, Medical Equipments and Devices (Control Estatal de Medicamentos, Equipos y Dispositivos Médicos, CECMED).

Biosimilars approved in Peru

In Peru, the regulatory body responsible for approving biological drugs is the General Directorate of Medicines, Supplies and Drugs (DIGEMID) of the Peruvian Ministry of Health (MINSA) which is in charge of leading the National and Decentralised Health System, the policy for the universal health assurance and the policies and intersectoral actions on social determinants [1].

Biosimilars approved in Uruguay

In Uruguay, the regulatory body responsible for the approval of biologicals is the Ministry of Public Health of Uruguay (Ministerio de Salud Pública de Uruguay, MSP).

Biosimilars approved in Costa Rica

In Costa Rica, the regulatory body responsible for the approval of biologicals is the Ministry of Health.

Interchangeable insulin glargine biosimilar preferred on Express Scripts

The interchangeable insulin glargine biosimilar, Semglee, has been listed by Express Scripts, America’s largest pharmacy benefit management organization, as a preferred insulin brand on its National Preferred Formulary (NPF), which includes more than 28 million lives in the US.

Argentinian gastroenterologist groups issued position statement on biosimilars use

Experts from the steering committees of the Argentinian Society of Gastroenterology (SAGE), the Argentinian Federation of Gastroenterology (FAGE) and the Argentinian Group of Crohn's Disease and Ulcerative Colitis (GADECCU) have issued a joint position regarding the practical conditions for the clinical use of biosimilars indicated for inflammatory bowel diseases (IBDs), by discussing the most notable aspects related to the definition of a biosimilar drug, bio-similarity, non-comparable biological drugs or ‘intended copies’, approval requirements, extrapolation of indications, interchangeability, automatic substitution, non-medical switching, nomenclature, clinical standards regarding safety and efficacy, implementation of an efficient and appropriate pharmacovigilance system and the potential economic impact on the healthcare system [1].

Potential biotech collaboration between India and Colombia

A letter of intent on cooperation in biotechnology has been signed between India and Colombia, which could include collaborations on vaccines, biosimilars, and medical devices.

China approving more copy biologicals since new guidelines introduced

China has approved many more copy biologicals in the last three years. A move which, according to Pharmaceutical Technology, is thought could be due to the introduction of new guidelines for the products.

New Zealand to expand access to rituximab, possibly adalimumab

New Zealand’s Pharmaceutical Management Agency, Pharmac, has announced a decision to expand access to rituximab and has launched a proposal to expand access to adalimumab.

Off-patent biologicals/Biomimics approved in Bolivia

In Bolivia, the regulatory body for the approval of biologicals is the State Agency for Medicines and Health Technologies AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud).

Interactive map for interchangeable biosimilars

US-based healthcare services company Cardinal Health has launched an interactive map for interchangeable biosimilars as part of its information for biosimilars.

Biosimilars, innovation in the treatment of chronic disease

Biological therapies have meant a significant advance in the way of treating various chronic conditions such as cancer, rheumatoid arthritis, multiple sclerosis. However, they have brought with them high costs for health systems that have been channelled through supply programmes of this type of drugs, in the case of the Dominican Republic, through the High Cost Medicines Programme.

Biosimilars of insulin aspart

Last update: 27 August 2021

Insulin aspart is a type of manufactured insulin used to treat type 1 and type 2 diabetes. It has a more rapid onset and a shorter duration of activity than normal human insulins.

Biosimilars applications under review by EMA – July 2021

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.

Quebec announces biosimilar switching policy

Quebec, Canada has announced a biosimilar switching policy, which is expected to generate annual savings of CA$100 million at its conclusion in 2022.

Biosimilars as a sustainable alternative for complex diseases

The use of ‘similar biotherapeutic’ products and ‘biocomparable’ medicines, as biosimilar medicines are named in Colombia and Mexico, respectively, offer a sustainable alternative for health systems, leading to significant savings for payers and health institutions, as well as market opening. Biosimilars thus provide a fair competitive solution.

PANLAR issues consensus statement on biosimilars

PANLAR presented its position on biosimilar medicines at its own congress in Argentina. Via the consensus statement, the PANLAR specialists seek to demonstrate the efficacy, pharmacovigilance, regulation, quality and safety of biosimilar medicines.

Biosimilar pipelines for South Korean firms: LG Chem and GC Pharma

Biosimilar makers from South Korea are making their mark, not only in South Korea, but around the world when it comes to biosimilars. Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture) are already becoming major players in the world of biosimilars. While, other Korean companies, such as LG Chem Life Sciences (LG Chem) and GC Pharma (formerly Green Cross) are also expanding their biosimilar pipelines.

US biosimilars information guides and support for cancer biosimilars

Pharmaceutical giant, Pfizer, and the Cancer Support Community, in the US, have published guides to biosimilars. In addition, Pfizer is collaborating with The National Comprehensive Cancer Network® (NCCN®) to fund projects to support innovation related to appropriate biosimilar adoption in oncology.

Biobadamérica promotes the use of biological and biosimilar drugs in Latin America

In 2007, the Spanish Society of Rheumatology (Sociedad Española de Reumatología, SER) created the Biobadamérica, an international collaborative project to promote the implementation of national safety registries for the use of biological and biosimilar drugs in Latin American countries [1]. 

The role of the patient in treatments with biosimilars in Argentina

This is how Dr Eduardo Mysler, Medical Director for the Research Medical Organization (OMI) and rheumatology specialist with a long research career reflects that ‘patients have to understand all the details of their disease’.

US Supreme Court rejects Enbrel patent challenge from Sandoz

The US Supreme Court has declined to review a patent challenge from Sandoz on Amgen’s blockbuster anti-inflammatory, Enbrel (etanercept). This means Sandoz will not be able to launch its etanercept biosimilar, Erelzi (etanercept-szzs), on the US market until 2029. 

Biosimilar pipelines for South Korean firms: Celltrion and Samsung Bioepis

Biosimilars are becoming more important around the world and Korean companies, such as Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture), are fast becoming major players both in Korea but also worldwide.

Dramatic price reduction of trastuzumab in Malaysia

The price of the cancer drug trastuzumab has dropped by more than half in Malaysia following a recent tender to the Ministry of Health.

Biosimilar pipelines for South Korean firms: Chong Kun Dang, DM Bio and HK inno.N

South Korea is becoming a more and more important spot on the map when it comes to biosimilars. Although Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture) are leading the way in Korea and worldwide, other Korean companies, such as Chong Kun Dang Pharmaceutical (Chong Kun Dang), DM Bio (joint venture between Dong-A ST and Meiji Holdings) and HK inno.N (previously CJ Healthcare), are also expanding their biosimilar pipelines.

Approved biosimilars for South Korean firms: Celltrion and Samsung Bioepis

Korean companies, such as Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture), are becoming more and more important both in the country and worldwide when it comes to developing biosimilars.

Canadian provinces expand their use of biosimilars

New Brunswick has become the third Canadian province to implement a biosimilar switching policy. The province of Alberta has also expanded its switching programme to include biosimilars of the anti-inflammatory treatment adalimumab (Humira). 

Safety of switching between rituximab biosimilars in cancer

In more than 10 years of clinical experience, no substantial clinical and safety differences have been detected among biosimilars and their already approved biologicals [1]. However, concerns are raised with respect to the practice of switching in patients already treated with a specific biological product (either reference or biosimilar) [2].

Insurer formularies increase complexity for healthcare providers

An assessment of insurer formularies for pegfilgrastim in the US suggests that payer-imposed preferences increase complexity when pharmacists and physicians are choosing which version of a drug to stock and administer.  

Rheumatoid arthritis treatments in Australia

Analysis of the treatment landscape for rheumatoid arthritis in Australia shows that AbbVie’s Humira (adalimumab) and Pfizer’s Enbrel (etanercept) together make up half of total sales.

Biosimilars of enoxaparin sodium

Enoxaparin sodium is an anticoagulant medication (blood thinner). It is used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) including during pregnancy and following certain types of surgery. It is also used in those with acute coronary syndrome (ACS) and heart attacks.

British Columbia adds adalimumab to biosimilar switching programme

British Columbia (BC), the first province in Canada to switch patients to biosimilar drugs, has added adalimumab to its switching programme. Almost 6,000 patients will be transitioned from originator adalimumab (Humira) to one of five biosimilar versions.

Biosimilars of ustekinumab

Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors. It is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis.

Biosimilars of aflibercept

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor. It is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy in patients with diabetic macular oedema.

Copy biologicals approved in China

Last update: 2 April 2021

In China, the regulatory body for the approval of medicines, including biologicals, is the National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA: simplified Chinese: 国家食品药品监督管理局).

Biosimilars approved in South Korea

Last update: 26 March 2021

In South Korea, the regulatory body for the approval of medicines, including biologicals and biosimilars, is the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration.

IVM releases toolbox on how to switch patients to insulin biosimilars

The Dutch Instituut voor Verantwoord Medicijngebruik (Institute for Responsible Medicines Use, IVM) has released a toolbox for healthcare providers on how to switch patients to insulin biosimilars.

Biosimilar patent litigation trends in the US

According to authors from Law360 the trend in biosimilar patent litigation cases has been downward, with many cases being resolved and only five cases still pending as of 31 December 2020 [1].

Biosimilar approvals and launches in the US

An examination of biosimilar approvals by the US Food and Drug Administration (FDA) compared to launches was carried out by authors from Law360 [1].

Biosimilar approvals and patent litigation in the US

Authors from Law360 have examined biosimilar approvals by the US Food and Drug Administration (FDA) under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and ensuing patent litigation actions. They also discuss why the lack of new approvals and litigation in 2020 does not suggest reduced interest in biosimilars but signals a new wave of biosimilars on the horizon [1].

Biosimilars of bevacizumab

Last update: 5 February 2021

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.

Samsung biosimilars: denosumab clinical trials begin, while rituximab development is halted

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) has initiated phase III trials for its denosumab biosimilar, while development on a rituximab biosimilar through subsidiary company Archigen Biotech has been stopped.

Biosimilars of filgrastim

Last update: 22 January 2021

Filgrastim is a granulocyte colony-stimulating factor (G-CSF). Filgrastim treatment can be used to stimulate the bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy for cancer treatment.

Biosimilars applications under review by EMA – January 2021

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 pegfilgrastim

Last update: 15 January 2021

Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

Biosimilars of trastuzumab

Last update: 15 January 2021

Trastuzumab is a monoclonal antibody that binds to and inactivates the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancers, HER2 is over-expressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat HER2 positive (HER2+) breast cancers.

Biosimilars in Australia – a-flagging and sustainability

Australia first introduced guidelines for biosimilars back in August 2008 when it adopted a number of guidelines from the EU on similar biological medicinal products [1].

Biosimilars of rituximab

Last update: 8 January 2021

Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.

Biosimilar advances for Samsung Bioepis

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) has announced several advances related to its infliximab, denosumab and ranibizumab biosimilars. These announcements come after the company revealed soaring sales figure in Europe.

Biosimilars of denosumab

Last update: 11  December 2020

Denosumab is a humanized monoclonal antibody that is an inhibitor of the receptor activator of nuclear factor kappa-B ligand (RANKL), which works by preventing the development of osteoclasts which are cells that break down bone. It is used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone and giant cell tumour of bone.

Biosimilars of teriparatide

Last update: 11 December 2020

Teriparatide is a recombinant form of parathyroid hormone (PTH). Teriparatide is identical to a portion of human PTH and intermittent use activates osteoblasts more than osteoclasts, which leads to an overall increase in bone. This makes it an effective anabolic, i.e., bone growing, agent. It is therefore used for the treatment of osteoporosis in postmenopausal women and men at high risk for fracture and for glucocorticoid-induced osteoporosis in men and postmenopausal women.

Genentech sues Centus over Avastin biosimilar

Genentech Inc. filed a complaint against Centus in the United States (US) state of Texas on 15 November 2020. It is alleged that Centus’s Equidacent, a biosimilar to Genentech’s Avastin (bevacizumab), infringes 10 US patents. 

Biosimilars of ranibizumab

Last update: 4 December 2020

Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. Ranibizumab inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor A (VEGF-A), a mechanism similar to bevacizumab [1]. 

Biosimilars of tocilizumab

Last update: 4 December 2020

Tocilizumab is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). It is an immunosuppressive drug used mainly for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis, a severe form of arthritis in children. In Japan, tocilizumab is also approved for the treatment of Castleman’s disease, a rare benign tumour of B cells.

Biosimilar toolkit for cancer patients

The European Cancer Patient Coalition (ECPC) has launched a biosimilars e-module, or toolkit [1]. This aims to teach patients about the value of biosimilars. 

Biosimilars of infliximab

Last update: 27 November 2020

Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

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.

Alberta Biosimilars Initiative: switching policy updates in Canada

The Alberta government in Canada has announced updates to the Alberta Biosimilars Initiative. 

Biosimilars of darbepoetin alfa

Last update: 20 November 2020

Darbepoetin alfa is a synthetic form of erythropoietin. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.

Biosimilar advances for Celltrion Healthcare

South Korea-based biotechnology company Celltrion Healthcare announced advances related to their infliximab, omalizumab and adalimumab biosimilars.

GBMA publishes information resources on biosimilars for consumers and carers

The Generic and Biosimilar Medicines Association (GBMA), the representative body of generic and biosimilar medicine suppliers in Australia, has recently published information resources for consumers and carers on biosimilars.

Biosimilars applications under review by EMA – July 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.

International Psoriasis Council releases consensus statement on biosimilars

The International Psoriasis Council (IPC) Biosimilar Working Group (BSWG) published their consensus statements for the use of biosimilars in the treatment of patients with psoriasis [1]. 

Australian diabetes organizations issue biosimilars position statement

In June 2020, the Australian Diabetes Society, Australian Diabetes Educators Association and Diabetes Australia, published a position statement on the use of biosimilar ‘insulins’ for diabetes.

Sustainable market scorecard represents gold-standard for biosimilar sustainability

IQVIA Institute and Medicines for Europe have recently launched Country Scorecards for Biosimilar Sustainability in 12 European countries [1]. The scorecards assess the level of competition, price evolution and volume development for seven key biological molecules – adalimumab, etanercept, infliximab, insulin glargine, insulin lispro, rituximab and trastuzumab – in each country. They also present a sustainability assessment and detail positive policy elements, challenges and solutions for each country.

FDA updates Purple Book database

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.

Country scorecards show biosimilar sustainability

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.

Duopharma to establish Malaysia’s first commercial biosimilar facility

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.

WHO prequalifies Celltrion’s trastuzumab biosimilar Herzuma

The World Health Organization (WHO) has prequalified Celltrion Healthcare’s second biosimilar, a trastuzumab biosimilar sold as Herzuma.

Clinical trials for trastuzumab biosimilars

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.

Biosimilar pipelines for Korean firms looking healthy

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

New Zealand IBD charity releases position statement on biosimilars

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.

Switching from biologicals to biosimilars in Australia

Switching* patients from originator biologicals to biosimilars has been a topic of keen interest in recent years across the globe, as more biosimilars have emerged onto the market. Authors from Shelston Intellectual Property discussed the unique approach that Australia has taken to switching.

Medscape hosts virtual symposium on biosimilars in IBD

Medscape held a virtual symposium on the use of biosimilars in inflammatory bowel disease (IBD) on 30 May 2020. The event covered issues including the regulatory approval process for biosimilars, research on biosimilars and switching.

ISOPP publishes a whole host of information on biosimilars

The International Society of Oncology Pharmacy Practitioners (ISOPP) has published a whole host of information on biosimilars in a supplementary issue of the Journal of Oncology Pharmacy Practice.

WHO prequalifies first rituximab biosimilar

The World Health Organization (WHO) has prequalified its first rituximab biosimilar as part of its efforts to make life-saving treatments more affordable and available to patients globally.

Biosimilar Awareness Week in Australia

The second Biosimilar Awareness Week took place on 25–29 May 2020 in Australia. It involved discussion on social media and aimed to increase awareness and confidence in biosimilars among consumers and healthcare professionals.