Biosimilars/News

Positive phase I results for Cinfa’s pegfilgrastim biosimilar

Biosimilars/News | Posted 19/05/2017

Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 17 May 2017 that results from the second phase I study of its pegfilgrastim biosimilar (B12019) had met its primary endpoints.

Second infliximab biosimilar to be launched in Australia in 2Q 2017

Biosimilars/News | Posted 12/05/2017

Merck Sharp and Dohme (MSD) announced on 1 May 2017 its intention to launch the infliximab biosimilar Renflexis in the second half of 2017.

FDA approves biosimilar infliximab Renflexis

Biosimilars/News | Posted 04/05/2017

Samsung Bioepis announced on 24 April 2017 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Johnson & Johnson and Merck’s Remicade (infliximab).

EMA approval for etanercept and rituximab biosimilars

Biosimilars/News | Posted 28/04/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 21 April 2017 that it had recommended granting marketing authorization for the etanercept biosimilar Erelzi and for the rituximab biosimilars Rixathon and Riximyo.

Advances in ranibizumab and teriparatide biosimilars

Biosimilars/News | Posted 21/04/2017

Positive results have been reported from a ranibizumab biosimilar and a teriparatide biosimilar has entered phase III trials.

Trastuzumab biosimilar submitted for approval in Japan

Biosimilars/News | Posted 14/04/2017

Japan-based Nippon Kayaku announced on 11 April 2017 that it had submitted an application for its trastuzumab biosimilar, CT-P6, to the Ministry of Health, Labour and Welfare (MHLW) in Japan.

Basal analogue insulin ‘copy biological’ launched in Indonesia

Biosimilars/News | Posted 07/04/2017

Indonesian generics maker Kalbe Pharma (Kalbe) announced on 25 March 2017 the launch of a basal analogue insulin ‘copy biological’ in Indonesia.

EC approval for adalimumab biosimilar Amgevita

Biosimilars/News | Posted 31/03/2017

Biotech giant Amgen announced on 23 March 2017 that the European Commission (EC) had granted marketing authorization for its adalimumab biosimilar Amgevita.

Amgen submits trastuzumab biosimilar to EMA

Biosimilars/News | Posted 24/03/2017

Biotech giant Amgen announced during a conference presentation that it had filed for marketing approval for its trastuzumab biosimilar (ABP 980) in the European Union (EU).

Global settlement clears a pathway for trastuzumab biosimilar

Biosimilars/News | Posted 17/03/2017

Generics giant Mylan Pharmaceuticals (Mylan) announced on 13 March 2017 that it had agreed to the terms of a global settlement with Genentech and Roche in relation to patents for Herceptin (trastuzumab), which provides Mylan with global licences for its trastuzumab biosimilar.

Russian approval for non-originator interferon beta-1a

Biosimilars/News | Posted 10/03/2017

Russian biotechnology company Biocad announced on 3 March 2017 that the Russian Ministry of Health had approved the company’s interferon beta-1a non-originator biological drug, BCD-033. The drug is a non-originator biological of Merck’s multiple sclerosis blockbuster Rebif (interferon beta-1a).

EC approval for first cancer biosimilar Truxima

Biosimilars/News | Posted 03/03/2017

South Korean biotechnology company Celltrion announced on 22 February 2017 that it had received European Commission (EC) approval for the marketing authorization for its rituximab biosimilar Truxima.

FDA accepts application for Mylan/Biocon’s pegfilgrastim biosimilar

Biosimilars/News | Posted 24/02/2017

Mylan and Biocon announced on 16 February 2017 that the regulatory submission for their proposed pegfilgrastim biosimilar (MYL-1401H) had been accepted by the US Food and Drug Administration (FDA).

Biocon wins three-year contract to supply insulin in Malaysia

Biosimilars/News | Posted 24/02/2017

Biocon has been awarded a contract by the Malaysian Ministry of Health to supply recombinant human insulin formulations to the country, a deal reportedly worth US$68 million.

Etanercept biosimilar submitted for approval in Japan

Biosimilars/News | Posted 17/02/2017

Japan-based Mochida Pharmaceutical (Mochida) has submitted an application for marketing approval for an etanercept biosimilar (LBEC0101) to the Japanese medicines regulatory agency – the Pharmaceuticals and Medical Devices Agency (PMDA).

EMA approval for adalimumab biosimilars Amgevita and Solymbic

Biosimilars/News | Posted 10/02/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 January 2017 that it had recommended granting of marketing authorization for the adalimumab biosimilars Amgevita and Solymbic.

Sandoz withdraws biosimilar pegfilgrastim application

Biosimilars/News | Posted 03/02/2017

The European Medicines Agency (EMA) announced on 27 January 2017 that Sandoz had withdrawn the marketing application for its pegfilgrastim biosimilar (Zioxtenzo), after the agency expressed doubts about its biosimilarity and manufacturing.

Boehringer Ingelheim submits biosimilar adalimumab application to both EMA and FDA

Biosimilars/News | Posted 27/01/2017

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) announced on 18 January 2017 that its candidate adalimumab biosimilar (BI 695501) had been accepted for regulatory review by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

Merck Group starts phase III trial for adalimumab biosimilar

Biosimilars/News | Posted 18/03/2016

Germany’s Merck KGaA (Merck Group) announced on 2 March 2016 that it had started a phase III clinical trial for its adalimumab biosimilar (MSB11022) in patients with chronic plaque psoriasis.

Biosimilar adalimumab application submitted to EMA

Biosimilars/News | Posted 11/12/2015

Biotech giant Amgen announced on 4 December 2015 that it had submitted an application for marketing approval for its adalimumab biosimilar (ABP 501) to the European Medicines Agency (EMA).

Amgen submits biosimilar adalimumab application to FDA

Biosimilars/News | Posted 27/11/2015

Biotech giant Amgen announced on 25 November 2015 that it had submitted an application for marketing approval for its adalimumab biosimilar (ABP 501) to the US Food and Drug Administration (FDA).

Venezuelan approval for Celltrion’s Remsima

Biosimilars/News | Posted 08/05/2015

Celltrion announced on 29 April 2015 that it had received approval for its infliximab bioterapéuticos similares from the Venezuelan medicines agency, the Instituto Nacional de Higiene ‘Rafael Rangel’ (INHRR National ‘Rafael Rangel’ Institute of Hygiene).

The latest biosimilars agreements

Biosimilars/News | Posted 09/11/2012

Biosimilar is still the hottest subject around. Just a few of the latest collaborations for the development of biosimilars include agreements made on 6 November 2012 between AET BioTech and BioXpress Therapeutics; Oncobiologics and Boston Oncology; ProCognia and UniTargetingResearch; and the Innovent Biologics and Pharmatech Associates agreement made on 1 November 2012.

Japanese firms developing biosimilars

Biosimilars/News | Posted 09/11/2012

Japanese firms are definitely not dragging their heels when it comes to biosimilars. The latest agreement for biosimilar development involves LG Life Sciences (LGLS) and Mochida Pharmaceutical (Mochida), while joint venture Fujifilm Kyowa Kirin Biologics has announced it is to initiate development of a biosimilar version of bevacizumab.

Protalix plant-produced Enbrel biosimilar effective in preclinical models

Biosimilars/News | Posted 22/10/2009

Protalix Biotherapeutics reported preclinical data on pr-antiTNF, a biosimilar version of etanercept (Enbrel). Produced using the company's proprietary ProCellEx technology, pr-antiTNF is a plant cell–expressed recombinant fusion protein made from the soluble form of the human TNF receptor (TNFR), fused to the Fc component of a human antibody IgG1 domain. Pr-antiTNF has an identical amino acid sequence to Enbrel. In vitro and preclinical animal studies have demonstrated that pr-antiTNF exhibits similar activity to Enbrel. Specifically, pr-antiTNF binds TNF-alpha thereby inhibiting it from binding to cellular surface TNF receptors and protects L929 cells from TNF-induced apoptosis in a dose-dependent manner. In a proof-of-concept in vivo study using an established arthritis animal model, pr-antiTNF administered intraperitoneally significantly improved the clinical arthritis parameters associated with this accepted arthritis mouse model, including joint inflammation, swelling and tissue degradation. Data from the collagen-induced arthritis animal model studies are expected to be presented at an upcoming scientific conference.

Biosimilar EPO and infliximab, adalimumab get formal Japanese approval

Biosimilars/News | Posted 17/02/2010

As reported by Scrip on 21 January 2010, a large batch of new products has received final approval from Japan's ministry of health, labour and welfare, including a biosimilar erythropoietin. These and the other products given formal approval by the ministry received positive recommendations in November and December 2009.

EMA approval for rituximab biosimilar Truxima

Biosimilars/News | Posted 20/01/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 16 December 2016 that it had recommended granting of marketing authorization for a rituximab biosimilar.

Benepali gains approval for extra indications

Biosimilars/News | Posted 13/01/2017

Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen, announced on 16 December 2016 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion for the extension of indications for its etanercept biosimilar Benepali

EMA accepts application for pegfilgrastim biosimilar from Coherus

Biosimilars/News | Posted 06/01/2017

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 29 November 2016 that its application for approval for its proposed pegfilgrastim biosimilar (CHS 1701) had been accepted by the European Medicines Agency (EMA).

Bevacizumab biosimilar application submitted to EMA

Biosimilars/News | Posted 09/12/2016

Biotech giant Amgen and its partner Allergan announced on 2 December 2016 that they had submitted their application for approval for their proposed bevacizumab biosimilar (ABP 215) to the European Medicines Agency (EMA). The companies believe this submission is the first bevacizumab biosimilar application submitted to EMA.

Mylan and Biocon submit trastuzumab biosimilar to FDA

Biosimilars/News | Posted 09/12/2016

Generics giant Mylan Pharmaceuticals (Mylan) and Indian biosimilars major Biocon announced on 8 November 2016 that they had submitted the marketing application for their proposed trastuzumab biosimilar (Myl-1401O) to the US Food and Drug Administration (FDA).

Teva and Celltrion to partner on biosimilars

Biosimilars/News | Posted 14/10/2016

Israeli generics giant Teva Pharmaceutical Industries (Teva) and South Korean biotechnology company Celltrion announced on 7 October 2016 that they had entered into an exclusive partnership for two of Celltrion’s monoclonal antibody biosimilars in the US and Canada.

Biosimilar rituximab approved in South Korea

Biosimilars/News | Posted 02/12/2016

South Korean biotechnology company Celltrion announced on 17 November 2016 that the company had received approval for its rituximab biosimilar Truxima (CT-P10) from the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).

Mylan and Biocon submit insulin glargine biosimilar to EMA

Biosimilars/News | Posted 02/12/2016

Generics giant Mylan Pharmaceuticals (Mylan) and Indian biosimilars major Biocon announced on 3 November 2016 that the regulatory submission for their proposed insulin glargine biosimilar had been accepted for review by the European Medicines Agency (EMA).

FDA accepts application for bevacizumab biosimilar

Biosimilars/News | Posted 25/11/2016

Biotech giant Amgen and its partner Allergan, announced on 15 November 2016 that the regulatory submission for its proposed bevacizumab biosimilar (ABP 215) had been accepted for review by the US Food and Drug Administration (FDA). The companies believe this submission is the first bevacizumab biosimilar application submitted to FDA.