Biosimilars/General

South Korea’s Celltrion to sell directly to Australia

Biosimilars/General | Posted 09/08/2019

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?’

Biosimilars/General | Posted 02/08/2019

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

Biosimilars/General | Posted 26/07/2019

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

Biosimilars/General | Posted 14/06/2019

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

Biosimilars/General | Posted 14/06/2019

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

Biosimilars/General | Posted 07/06/2019

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

Biosimilars/General | Posted 31/05/2019

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

Biosimilars/General | Posted 31/05/2019

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

Biosimilars/General | Posted 24/05/2019

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

Biosimilars/General | Posted 17/05/2019

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

Biosimilars/General | Posted 10/05/2019

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

Biosimilars/General | Posted 26/04/2019

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

Biosimilars/General | Posted 19/04/2019

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

Biosimilars/General | Posted 12/04/2019

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

Biosimilars/General | Posted 06/03/2015

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

Biosimilars/General | Posted 30/01/2015

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.

Biosimilars of somatropin

Biosimilars/General | Posted 01/04/2019

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

Biosimilars/General | Posted 05/04/2019

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

Biosimilars/General | Posted 05/04/2019

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

Biosimilars/General | Posted 22/03/2019

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

Biosimilars/General | Posted 01/03/2019

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

Biosimilars/General | Posted 08/03/2019

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

Biosimilars/General | Posted 25/01/2019

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

Biosimilars/General | Posted 01/02/2019

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

Biosimilars/General | Posted 18/01/2019

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/General | Posted 11/01/2019

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

Biosimilars/General | Posted 14/12/2018

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

Biosimilars/General | Posted 14/12/2018

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

Biosimilars/General | Posted 25/01/2019

Boehringer Ingelheim and Sandoz abandon biosimilars

Biosimilars/General | Posted 07/12/2018

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

Biosimilars/General | Posted 02/11/2018

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

Biosimilars/General | Posted 26/10/2018

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

Biosimilars/General | Posted 12/10/2018

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

Biosimilars/General | Posted 05/10/2018

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

Biosimilars/General | Posted 28/09/2018

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

Biosimilars/General | Posted 21/09/2018

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

Extension of indications and manufacturing approval for biologicals in the US

Biosimilars/General | Posted 14/09/2018

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

Biosimilars/General | Posted 07/09/2018

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

Biosimilars/General | Posted 24/08/2018

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

Biosimilars/General | Posted 13/07/2018

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).