Biosimilars/News

FDA accepts application for rituximab biosimilar from Sandoz

Biosimilars/News | Posted 29/09/2017

Sandoz, the generics division of Novartis, announced on 12 September 2017 that the regulatory submission for its proposed rituximab biosimilar (GP2013) had been accepted by the US Food and Drug Administration (FDA).

FDA approves bevacizumab biosimilar Mvasi

Biosimilars/News | Posted 22/09/2017

On 14 September 2017, the US Food and Drug Administration (FDA) approved its first biosimilar for the treatment of cancer.

Second etanercept biosimilar approved in Canada

Biosimilars/News | Posted 22/09/2017

Sandoz, the generics division of Novartis, announced on 21 August 2017 that its etanercept biosimilar, Erelzi, is now available in Canada.

Sanofi receives tentative FDA approval for insulin lispro biosimilar

Biosimilars/News | Posted 15/09/2017

Pharma giant Sanofi announced on 1 September 2017 that it had received tentative approval for Admelog, its insulin lispro biosimilar, from the US Food and Drug Administration (FDA).

Two trastuzumab biosimilars submitted to FDA

Biosimilars/News | Posted 15/09/2017

Two different groups announced that their trastuzumab biosimilars had been successfully submitted to the US Food and Drug Adminstration (FDA) for review.

EC approval for three rituximab biosimilars

Biosimilars/News | Posted 08/09/2017

On 13 July 2017, three rituximab biosimilars, Blizima, Rituzena (previously Tuxella) and Ritemvia, received European Commission (EC) approval.

Boehringer Ingelheim starts phase III interchangeability trial for adalimumab biosimilar

Biosimilars/News | Posted 08/09/2017

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) announced on 27 July 2017 that the first patient had been enrolled into the phase III VOLTAIRE‑X interchangeability study of its adalimumab biosimilar (BI 695501). The company says the trial ‘is the first study in the US to investigate an interchangeability designation for an adalimumab biosimilar candidate’.

FDA approves adalimumab biosimilar Cyltezo

Biosimilars/News | Posted 01/09/2017

On 25 August 2017, the US Food and Drug Administration (FDA) approved its second biosimilar version of AbbVie’s Humira (adalimumab).

EC approval for adalimumab biosimilar Imraldi

Biosimilars/News | Posted 01/09/2017

Samsung Bioepis announced on 25 August 2017 that it had received European Commission (EC) approval for its biosimilar adalimumab product Imraldi.

Hanwha to transfer biosimilar etanercept technology to Merck KGaA

Biosimilars/News | Posted 06/02/2015

South Korea’s Hanwha Chemical Corporation (Hanwha) has reportedly signed a contract with German drug maker Merck KGaA (Merck Group) to export the technology to make its biosimilar etanercept drug.

Biocad’s rituximab ‘similar biologic’ recommended for approval in India

Biosimilars/News | Posted 18/08/2017

Russian biotechnology company Biocad announced on 4 July 2017 that it would ‘soon’ receive marketing approval for its rituximab ‘similar biologic’ in India under the trade name Acellbia.

FDA accepts application for Celltrion/Teva’s rituximab biosimilar

Biosimilars/News | Posted 11/08/2017

South Korean biotechnology company Celltrion and partner Israeli generics giant Teva Pharmaceuticals (Teva) announced on 29 June 2017 that the regulatory submission for their proposed rituximab biosimilar (CT‑P10) had been accepted by the US Food and Drug Administration (FDA).

FDA rejects Pfizer’s epoetin alfa biosimilar

Biosimilars/News | Posted 14/07/2017

US pharma giant Pfizer announced on 22 June 2017 that the US Food and Drug Administration (FDA) had rejected its application for approval of its epoetin alfa biosimilar.

Biocad registers rituximab similar biotherapeutic product in Bolivia and Honduras

Biosimilars/News | Posted 14/07/2017

Russian biotechnology company Biocad announced on 6 June 2017 that it had obtained a marketing authorization for its rituximab ‘similar biotherapeutic product’ in Bolivia and Honduras under the trade name Usmal.

EC approval for etanercept biosimilar Erelzi

Biosimilars/News | Posted 07/07/2017

Sandoz, the generics division of Novartis, announced on 27 June 2017 that it had received European Commission (EC) approval for its biosimilar etanercept product Erelzi.

FDA rejects pegfilgrastim biosimilar from Coherus

Biosimilars/News | Posted 07/07/2017

Coherus BioSciences (Coherus) announced on 12 June 2017 that it had received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its candidate pegfilgrastim biosimilar, CHS‑1701.

EMA approval for adalimumab biosimilar Imraldi

Biosimilars/News | Posted 30/06/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 June 2017 that it had recommended granting marketing authorization for the adalimumab biosimilar Imraldi from Samsung Bioepis.

Adalimumab and infliximab biosimilars from Sandoz accepted for review by EMA

Biosimilars/News | Posted 30/06/2017

Sandoz, the generics division of Novartis, announced on 31 May 2017 that the regulatory submissions for its proposed adalimumab (GP2017) and infliximab (PF‑06438179) biosimilars had been accepted by the European Medicines Agency (EMA).

EC approval for rituximab biosimilar Rixathon

Biosimilars/News | Posted 23/06/2017

Sandoz, the generics division of Novartis, announced on 19 June 2017 that it had received European Commission (EC) approval for its biosimilar rituximab product Rixathon.

FDA advisors recommend approval of Pfizer’s epoetin alfa biosimilar

Biosimilars/News | Posted 16/06/2017

US Food and Drug Administration’s (FDA) advisers have voted to recommend the approval of Pfizer’s biosimilar version of Amgen/Johnson & Johnson’s Epogen/Eprex/Procrit (epoetin alfa).

Celltrion making progress with biosimilars in China and Japan

Biosimilars/News | Posted 16/06/2017

South Korean biotechnology company Celltrion has announced advances in its biosimilar rituximab and trastuzumab programmes in China and Japan.

FDA advisory committee to review bevacizumab and trastuzumab biosimilars

Biosimilars/News | Posted 09/06/2017

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) announced in a Federal Register Notice on 7 June 2017 that it would be reviewing bevacizumab and trastuzumab biosimilars at its next meeting.

EMA accepts application for adalimumab biosimilar from Fujifilm Kyowa Kirin Biologics

Biosimilars/News | Posted 02/06/2017

Japan-based biosimilars developer Fujifilm Kyowa Kirin Biologics announced on 22 May 2017 that its application for approval for its proposed adalimumab biosimilar (FKB327) had been accepted by the European Medicines Agency (EMA).

EMA approval for insulin and rituximab biosimilars

Biosimilars/News | Posted 26/05/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 19 May 2017 that it had recommended granting marketing authorization for Insulin lispro Sanofi and for the rituximab biosimilars Blitzima, Ritemvia and Tuxella.

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).