Biosimilars/News

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.

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.

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).

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.

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).

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).

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.

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.

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.

Applications for adalimumab and trastuzumab biosimilars submitted to FDA

Biosimilars/News | Posted 04/02/2022

Korea-based Samsung Bioepis and partner US-based Organon announced on 5 January 2022 that the US Food and Drug Administration (FDA) had accepted the application for their proposed citrate-free, high-concentration (100 mg/mL) adalimumab biosimilar (SB5). A low-concentration formulation of SB5, Hadlima (adalimumab-bwwd), was approved in the US in July 2019 [1].

FDA approves adalimumab and insulin glargine biosimilars Yusimry and Rezvoglar

Biosimilars/News | Posted 28/01/2022

The US Food and Drug Administration (FDA) has approved the adalimumab biosimilar Yusimry (adalimumab-aqvh) and the insulin glargine biosimilar Rezvoglar (insulin glargine-aglr) [1].

Canada approves adalimumab biosimilars Simlandi and Yuflyma

Biosimilars/News | Posted 21/01/2022

Canada’s drug regulator, Health Canada, has approved the adalimumab biosimilars Simlandi (AVT02) and Yuflyma (CT-P17).

Canada approves filgrastim biosimilar Nypozi

Biosimilars/News | Posted 14/01/2022

Canada’s drug regulator, Health Canada, has approved the filgrastim biosimilar Nypozi (TX01). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

Etanercept biosimilars delayed until 2029 in US

Biosimilars/News | Posted 14/01/2022

Yet another patent challenge to Amgen’s originator etanercept, Enbrel, has been denied in the US.

Positive phase III results for omalizumab copy biological

Biosimilars/News | Posted 27/05/2016

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 16 May 2016 that its partner, MabTech had successfully completed a combined phase II and III clinical trial in China for STI-004, a copy biological for omalizumab (Xolair). STI 004 met its primary endpoint in a multicentre, randomized, double-blind, placebo-controlled, clinical study.

New Zealand announces funding for adalimumab biosimilar

Biosimilars/News | Posted 17/12/2021

New Zealand has announced that, in order to widen access to adalimumab, it will now fund the adalimumab biosimilar Amgevita.

China approves three bevacizumab copy biologicals

Biosimilars/News | Posted 10/12/2021

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has approved three bevacizumab.

Celltrion seeks approval for bevacizumab biosimilar in Europe, US and Korea

Biosimilars/News | Posted 03/12/2021

South Korean biotechnology company Celltrion announced in October 2021 that it had applied for marketing approval for its candidate bevacizumab biosimilar (CT P16) in Europe, Korea and the US.

Adalimumab biosimilar launched in Japan

Biosimilars/News | Posted 03/12/2021

Japan-based Mochida Pharmaceutical (Mochida) announced on 25 November 2021 that its adalimumab biosimilar had been launched in Japan following the listing of the drug on the National Health Insurance (NHI).

Australian and Indian approval for teriparatide products

Biosimilars/News | Posted 02/04/2021

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has approved a teriparatide biosimilar and the Drug Controller General of India (DCGI) has approved a teriparatide ‘similar biologic’.

China accepts Bio-Thera’s application for tocilizumab copy biological BAT1806

Biosimilars/News | Posted 26/11/2021

China’s National Medical Products Administration (NMPA) has accepted a marketing authorization application for Bio-Thera Solutions’ (Bio-Thera) copy biological of tocilizumab, an immunosuppressant used in the treatment of arthritis.

Australia’s PBAC recommends unrestricted benefit listing for rituximab biosimilars

Biosimilars/News | Posted 19/11/2021

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the Pharmaceutical Benefits Scheme (PBS) listing for the rituximab biosimilars Riximyo and Truxima be changed to ‘Unrestricted Benefit listings’.

Canada approves filgrastim and insulin aspart biosimilars Nypozi and Kirsty

Biosimilars/News | Posted 12/11/2021

Canada’s drug regulator, Health Canada, has approved the filgrastim and insulin aspart biosimilars Nypozi and Kirsty.

China approves Factor VIII copy biological Anjian

Biosimilars/News | Posted 05/11/2021

China-based drugmaker SinoCellTech (formerly known as Shenzhou Cell) announced on 23 July 2021 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had approved its recombinant human coagulation factor VIII (susoctocog alfa) copy biological Anjian.

FDA approves adalimumab biosimilar Cyltezo as interchangeable

Biosimilars/News | Posted 29/10/2021

The US Food and Drug Administration (FDA) has approved the first interchangeable adalimumab biosimilar. This is the second interchangeable biosimilar to gain FDA approval in the US and follows the landmark decision to approve an interchangeable insulin glargine biosimilar in July 2021 [1].

Bio-Thera and Samsung Bioepis start clinical trials for ustekinumab biosimilars

Biosimilars/News | Posted 29/10/2021

China’s Bio-Thera Solutions and South Korea’s Samsung Bioepis have begun phase III clinical trials for biosimilars to Janssen’s blockbuster anti-inflammatory drug Stelara (ustekinumab).

Canada approves adalimumab and bevacizumab biosimilars

Biosimilars/News | Posted 22/10/2021

Canada’s drug regulator, Health Canada, has approved the bevacizumab biosimilar Bambevi and the adalimumab biosimilar Abrilada (PF-06410293).

Bioeq submits application for ranibizumab biosimilar to FDA

Biosimilars/News | Posted 15/10/2021

A ranibizumab biosimilar developed by Swiss biotechnology company Bioeq AG (Bioeq) has been successfully submitted to the US Food and Drug Administration (FDA) for review.

CuraTeQ submits application to EMA for pegfilgrastim biosimilar

Biosimilars/News | Posted 08/10/2021

India-based generics maker Aurobindo Pharma (Aurobindo) announced on 22 September 2021 that its subsidiary CuraTeQ Biologics (CuraTeQ) had submitted an application to the European Medicines Agency (EMA) for its pegfilgrastim biosimilar, BP14.

EMA recommends approval of two adalimumab biosimilars

Biosimilars/News | Posted 01/10/2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 17 September 2021 that it had recommended granting marketing authorization for the adalimumab biosimilars Hukyndra and Libmyris.

EC and FDA approval for first ranibizumab biosimilar Byooviz

Biosimilars/News | Posted 24/09/2021

On 18 August 2021, the ranibizumab biosimilar Byooviz (SB11), produced by Samsung Bioepis and commercialized by Biogen, received European Commission (EC) approval. Then on 20 September 2021 the pair announced that Byooviz had also received approval from the US Food and Drug Administration (FDA). This is the first ranibizumab biosimilar, or indeed ophthalmology biosimilar, to receive approval in either Europe or the US.

EC approval for insulin aspart biosimilar Kixelle

Biosimilars/News | Posted 26/03/2021

The European Commission (EC) has granted marketing authorization for the insulin aspart biosimilar Kixelle (MYL 1601D), developed by US-based drugmaker Mylan (now Viatris) and India-based biologicals specialist Biocon.

Canada approves insulin aspart biosimilar Trurapi

Biosimilars/News | Posted 12/02/2021

Canada’s drug regulator, Health Canada, has approved the insulin aspart biosimilar Trurapi.

EMA recommends approval of insulin aspart biosimilar Kixelle

Biosimilars/News | Posted 29/01/2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 December 2020 that it had recommended granting of marketing authorization for an insulin aspart biosimilar.

Bevacizumab biosimilars launched in Spain and Korea

Biosimilars/News | Posted 17/09/2021

New bevacizumab biosimilars have been launched in Spain and South Korea.

Mabpharm gains approval for infliximab biobetter in China

Biosimilars/News | Posted 10/09/2021

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 20 July 2021 that its partner, China-based Mabpharm, had received marketing approval from China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), for its infliximab ‘biobetter’ (CMAB008).