Biosimilars

US prescription drug expenditure projection report

Biosimilars/General | Posted 03/06/2022

United States expenditure on pharmaceuticals was up in 2021, finds a report published in American Journal of Health-System Pharmacy [1]. It also highlights that increased uptake of biosimilars is allowing for healthcare savings yet overall spending on drugs in the US will increase by up to 6% in 2022.

Lucentis biosimilars approved in the UK and Korea

Biosimilars/News | Posted 27/05/2022

The United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) and South Korea’s Ministry of Food and Drug Safety have approved biosimilar versions of Genentech’s ophthalmology drug, Lucentis (ranibizumab).

Patient perspectives on biosimilars in a high uptake country

Biosimilars/Research | Posted 27/05/2022

Several surveys have shown that challenges for patient acceptance of biosimilars include patients’ concerns of quality, safety, and efficacy [1-3], however, there has been lacking more in-depth knowledge of the patient perspective and the underlying rationales for such perspective. Therefore and considering Denmark has one of the highest biosimilar uptakes [4], Varma et al. [5] investigated how Danish patients with psoriasis, arthritic diseases, or inflammatory bowel disease (IBD) perceived biosimilars.

Biosimilar adoption and prescribing in Japan: a physician opinion survey

Biosimilars/Research | Posted 20/05/2022

Japanese physicians regularly request information on quality, efficacy, safety and cost burden to the patient when adopting or prescribing biosimilars, demonstrates a recent survey [1]. Higher biosimilars uptake may be achievable if such information was made more accessible and digestible.

New adalimumab biosimilars prepare to launch in Canada, US and Europe

Biosimilars/News | Posted 16/05/2022

Several new adalimumab biosimilar products are preparing to launch in Canada, the US and Europe, from manufacturers including BIOJAMP, Alvotech and Celltrion.

Innovent and Eli Lilly announce final results for sintilimab plus biosimilar bevacizumab injection

Biosimilars/Research | Posted 16/05/2022

Innovent and Eli Lilly have announced final clinical results for their sintilimab plus bevacizumab biosimilar injection, which has been accepted by China’s National Medical Products Administration (NMPA).

FDA approves Amneal’s bevacizumab biosimilar

Biosimilars/News | Posted 06/05/2022

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ (Amneal) bevacizumab biosimilar, Alymsys, the third bevacizumab biosimilar to be approved in the US.

Totality of evidence supporting approval of Avsola in the treatment of IBD

Biosimilars/Research | Posted 06/05/2022

Avsola (ABP 710) is a biosimilar to the infliximab reference product (Remicade), a monoclonal antibody targeting tumour necrosis factor-alfa. Avsola is approved in the US and Canada for all the same indications as Remicade, including adult and paediatric Crohn’s disease (CD), ulcerative colitis (UC), rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis [1, 2]. Infliximab is a highly efficacious treatment for inflammatory bowel disease (IBD), which includes CD and UC. The totality of evidence (TOE) supporting the development and approval of ABP 710 was recently reviewed [3].

Survey results of biosimilars use among Spanish physicians and pharmacists

Biosimilars/Research | Posted 06/05/2022

Marín-Jiménez I et al. published in April 2021 a report based on a survey that was launched in Spain between June and November 2020 among hospital pharmacists and specialty physicians (dermatology, rheumatology, gastroenterology) to analyse knowledge, perceptions, attitude, barriers and facilitators of biosimilars uptake. Response rate was close to 100%.

Europe: positive opinion for Inpremzia and Truvelog Mix 30 and Stimufend authorized

Biosimilars/News | Posted 29/04/2022

On 28 March 2022, the European Commission (EC) has granted marketing authorization for Fresenius Kabi's oncology biosimilar, Stimufend (pegfilgrastim); and the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 24 February 2022 that it had recommended granting of marketing authorization for an insulin aspart biosimilar and an insulin human (rDNA) biosimilar.

Amgen announces positive phase III results for ustekinumab biosimilar

Biosimilars/Research | Posted 29/04/2022

Amgen has announced positive results from a phase III trial of its ustekinumab biosimilar, ABP 654. The trial met its primary endpoint, demonstrating no clinically meaningful differences with the originator product, Stelara.

HHS new study on biosimilar use and expanded trials will include older patients

Biosimilars/General | Posted 29/04/2022

In March 2022, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced that it will launch a study on biosimilars use and spending trends in Medicare Part B. The US Food and Drug Administration (FDA) has also made changes to clinical trials to improve information available on use of biosimilars in older patients.

Regulating drug prices in Medicare unlikely to lead to ‘revenue targeting’

Biosimilars/Research | Posted 22/04/2022

A report from the American Enterprise Institute (AEI) suggests that regulating drug prices in Medicare is unlikely to lead manufacturers to compensate by increasing revenues from the commercial market, based on analysis of similar events in the European Union (EU).

Needle-free delivery of biological drugs from Rani and Progenity

Biosimilars/General | Posted 22/04/2022

Rani Therapeutics and Progenity have announced the respective launch and development of new oral, needle-free methods to deliver large biological drug molecules.

Secondary patents delay access to biosimilars in the US

Biosimilars/Research | Posted 15/04/2022

Biological drug patents covering new methods of manufacturing and formulation are major contributors to delays in biosimilar market entry in the US, finds a new study published in Nature Biotechnology [1].

FDA approves Kashiv Biosciences’ filgrastim biosimilar

Biosimilars/News | Posted 15/04/2022

The US Food and Drug Administration (FDA) has approved a filgrastim biosimilar produced by India-based Kashiv Biosciences. The biosimilar will be marketed under the trade name Releuko (filgrastim-ayow).

British Columbia adds coverage for three new enoxaparin biosimilars

Biosimilars/General | Posted 15/04/2022

British Columbia, Canada has added PharmaCare coverage for three new enoxaparin biosimilars, a blood thinner used to prevent and treat blood clots.

Celltrion updates on Remsima and Yuflyma

Biosimilars/News | Posted 08/04/2022

South Korean biotechnology company Celltrion announced two new data sets on the subcutaneous formulation Remsima (infliximab) in a number of conditions in March 2022. This followed the February 2022 announcement that the high-concentration version of Celltrion’s autoimmune disease biosimilar Yuflyma (adalimumab) has received approval from the European Commission.

Phase III trial evidence used in approval of ranibizumab biosimilar Byooviz

Biosimilars/Research | Posted 08/04/2022

Byooviz (SB11) is the first ranibizumab biosimilar approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) [1, 2].

Biocomparables approved in Mexico

Biosimilars/General | Posted 08/04/2022

In Mexico, biological products with expired patents are known as biocomparable biotechnology drugs (medicamentos biotecnológicos biocomparables). The regulatory body in charge of approving biocomparables is the Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS).

Trastuzumab biosimilar Kanjinti remains stable in polyolefin bags and elastomeric devices

Biosimilars/Research | Posted 01/04/2022

A study of the trastuzumab biosimilar ABP 980 (Kanjinti) finds that the compound remains stable in concentrated multi-dose bags and diluted in intravenous (IV) bags and elastomeric devices, providing preparation options to suit different global pharmacy practices.

Henlius makes deal with Getz Pharma for adalimumab copy biological

Biosimilars/News | Posted 01/04/2022

China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 23 February 2022 that it had entered into a licensing and supply agreement with Pakistan-based Getz Pharma for its adalimumab copy biological, Handa Yuan (汉达远; HLX03).

Consortium of US hospitals to manufacture and sell biosimilar insulin

Biosimilars/General | Posted 01/04/2022

A consortium of large US hospitals, through the non-profit company Civica Rx, are to manufacture and sell biosimilar insulin capped at US$30 per vial.

Are systematic switch studies for biosimilars necessary?

Biosimilars/Research | Posted 25/03/2022

A recently published review [1] questions the need for systematic switch studies to demonstrate the interchangeability of biosimilars, suggesting the studies are becoming obsolete.

Canada approves ranibizumab biosimilar Byooviz

Biosimilars/News | Posted 25/03/2022

The ranibizumab biosimilar Byooviz (SB11), produced by Samsung Bioepis and commercialized by Biogen, received approval from Canada’s drug regulator, Health Canada, on 8 March 2022. This is the first ranibizumab biosimilar to receive approval in Canada.

FDA accepts application for interchangeability of adalimumab biosimilar Abrilada

Biosimilars/News | Posted 18/03/2022

US-based pharma giant Pfizer announced on 25 February 2022 that the US Food and Drug Administration (FDA) had accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab).

The CROWN study: real-world comparison between ‘similar biologic’ and originator ranibizumab and bevacizumab

Biosimilars/Research | Posted 18/03/2022

The last decade and a half have witnessed a paradigm shift in the way vascular disorders affecting the retina are treated. Anti-vascular endothelial growth factor (VEGF) antibodies have become the mainstay of treatment. These monoclonal antibodies are injected in the vitreous cavity. For the treatment to be effective, repeated injections every 4 to 8 weeks over many years need to be given, which proves to be quite expensive.

Will the unclear path of biosimilar interchangeability become clearer?

Biosimilars/Research | Posted 11/03/2022

Biosimilar use has led to increased access to biological treatments for some molecules wherein switching from originator to biosimilar has been one means to exchange products [1, 2]. Another but less applied way to exchange the products is via substitution by a pharmacist, i.e. without informing the prescriber [2]. Substitution of biosimilars is a topic with many contrasting views and has been highly debated [3-12]. More clarity on the matter is needed because health care has reached a point where policy decisions need to be made about whether substitution should become a practice in biosimilar use. Therefore, researchers from Denmark, Sweden and The Netherlands investigated the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars [13].

Biosimilars approved in Argentina

Biosimilars/General | Posted 11/03/2022

In Argentina, the regulatory agency in charge of approving biological drugs is the National Administration of Drugs, Food and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT).

Generium launches omalizumab (Xolair) non-originator in Russia

Biosimilars/News | Posted 11/03/2022

Moscow’s Generium has launched a non-originator biological of omalizumab (Xolair) on the Russian market, the third of Generium’s products using Selexis’ SUREtechnology Platform to reach the market.

Europe’s IP framework should support earlier authorization of biosimilars, review finds

Biosimilars/Research | Posted 04/03/2022

A review of the European Pharmaceutical Strategy suggests the framework should focus on intellectual property (IP) initiatives that support the earlier authorization of biosimilars.

Key considerations when switching to biosimilar insulin

Biosimilars/General | Posted 04/03/2022

Biosimilar insulins can offer a cheaper alternative to originator insulators and substantial savings for healthcare systems. A recent ‘Quick guide: Initiating or switching to a biosimilar insulin’, [1] published in the Journal of Diabetes Nursing, outlines key aspects to consider when switching.

Biosimilars and non-medical switching among Saudi rheumatologists. The knowledge gap

Biosimilars/Research | Posted 25/02/2022

The increasing cost of originator biologicals, combined with consequences of the COVID-19 pandemic, have burdened the healthcare system. Unfortunately, the biosimilar uptake in Saudi Arabia has not reached an optimal level despite the approval of several agents. Therefore, physicians are essential stakeholders in the process and acceptance of biosimilars.

Nova Scotia, Canada implements biosimilar switching policy

Biosimilars/General | Posted 25/02/2022

Nova Scotia becomes the fifth Canadian province to implement a biosimilar switching policy, meaning that half of Canada’s provinces have now implemented such policies.

The US needs to learn from Europe to increasing access to biosimilars

Biosimilars/Research | Posted 18/02/2022

Europe has been leading the way when it comes to encouraging the use of biosimilars. This is especially true in Scandinavian countries, such as Norway, which are seen as leading the way when it comes to switching and substitution of biosimilars in Europe [1]. In fact, an analysis by Norwegian researchers has found that ‘tremendous savings’ could be realized in the US should the country implement similar strategies [2].

EMA recommends approval of teriparatide and pegfilgrastim biosimilars

Biosimilars/News | Posted 18/02/2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 28 January 2022 that it had recommended granting of marketing authorization for the teriparatide biosimilar Sondelbay and the pegfilgrastim biosimilar Stimufend.

Amgen predicts a steady flow of biosimilar launches

Biosimilars/General | Posted 18/02/2022

Amgen CEO Robert Bradway predicted expanding the company’s biosimilars business with a steady flow of biosimilar launches at the J.P. Morgan Healthcare Conference, which was held on 11 January 2022.

Biosimilars approved in Colombia

Biosimilars/General | Posted 11/02/2022

In Colombia, the regulatory body for the approval of biologicals is the National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA).

Real-world utilization of adalimumab biosimilar ABP 501

Biosimilars/Research | Posted 11/02/2022

In a poster presentation at the virtual Crohn’s & Colitis Congress, which took place on 20‒22 January 2022, a study describing real-world utilization of adalimumab biosimilar ABP 501 in patients with inflammatory bowel disease (IBD) in Europe was presented [1].

Lupin forms partnership to market pegfilgrastim biosimilar in Brazil

Biosimilars/News | Posted 11/02/2022

Indian multinational pharmaceutical company Lupin Ltd (Lupin) has signed an agreement with Brazilian firm Biomm SA to distribute and market a pegfilgrastim biosimilar in Brazil. In related news, Indian firm Gland Pharma has announced plans to enter the market for biosimilar manufacturing.