Biosimilars/General

PANLAR issues consensus statement on biosimilars

Biosimilars/General | Posted 16/07/2021

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

Biosimilars/General | Posted 09/07/2021

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

Biosimilars/General | Posted 02/07/2021

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

Biosimilars/General | Posted 25/06/2021

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

Biosimilars/General | Posted 21/06/2021

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

Biosimilars/General | Posted 11/06/2021

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/General | Posted 04/06/2021

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

Biosimilars/General | Posted 07/06/2019

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

Biosimilars/General | Posted 31/05/2021

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

Biosimilars/General | Posted 21/05/2021

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

Biosimilars/General | Posted 14/05/2021

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

Biosimilars/General | Posted 07/05/2021

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

Biosimilars/General | Posted 07/05/2021

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

Biosimilars/General | Posted 30/04/2021

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

Biosimilars/General | Posted 23/04/2021

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

Biosimilars/General | Posted 16/04/2021

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

Biosimilars/General | Posted 09/04/2021

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

Biosimilars/General | Posted 02/04/2021

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

Biosimilars/General | Posted 15/03/2019

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

Biosimilars/General | Posted 14/03/2014

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.

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