Biosimilars/News

EC approves ranibizumab biosimilar Ranivisio

Biosimilars/News | Posted 16/09/2022

On 29 August 2022, the ranibizumab biosimilar Ranivisio (FYB201), developed by Bioeq – a joint venture between Formycon and Polpharma Biologics, was granted marketing approval by the European Commission (EC).

Applications for natalizumab biosimilars accepted by FDA and EMA

Biosimilars/News | Posted 09/09/2022

Applications for natalizumab biosimilars made by Sandoz (the generics division of Novartis) and Polpharma Biologics (Polpharma) have been accepted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

FDA accepts application for tocilizumab biosimilar

Biosimilars/News | Posted 02/09/2022

Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 1 August 2022 that the US Food and Drug Administration (FDA) had accepted the application for their proposed tocilizumab biosimilar (MSB11456).

FDA approves first interchangeable ranibizumab biosimilar

Biosimilars/News | Posted 26/08/2022

Polpharma Biologics, Formycon and Bioeq jointly announced on 2 August 2022 that they had received approval from the US Food and Drug Administration (FDA) for their ranibizumab biosimilar (CHS-201/FYB201).

Innovent-Etana bevacizumab biosimilar approved in Indonesia

Biosimilars/News | Posted 29/07/2022

Innovent announced the approval of its bevacizumab biosimilar in Indonesia, that was developed in partnership with PT Etana Biotechnologies Indonesia.

Ranibizumab biosimilar, FYB201, receives EMA recommendation

Biosimilars/News | Posted 22/07/2022

Formycon’s ranibizumab biosimilar, FYB201, has received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).

New data on infliximab and adalimumab biosimilars at EULAR 2022

Biosimilars/News | Posted 15/07/2022

The Annual European Congress of Rheumatology (EULAR 2022) was held at the beginning of June 2022. This platform was used to announce the results of a study that showed that, in patients with rheumatoid arthritis, statistically greater improvements in clinical outcomes with subcutaneous infliximab, compared to intravenous infliximab. In addition, Samsung Bioepis announced new data on their established adalimumab biosimilar Imraldi (Hadlima outside Europe).

EMA accepts application for high concentration adalimumab biosimilar

Biosimilars/News | Posted 08/07/2022

Sandoz, the generics division of Novartis, announced on 17 June 2022 that the European Medicines Agency (EMA) has accepted the application for its high concentration formulation (HCF) of its adalimumab biosimilar Hyrimoz (GP2017).

EMA recommends approval of bevacizumab biosimilar Vegzelma

Biosimilars/News | Posted 01/07/2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 24 June 2022 that it had recommended granting marketing authorization for the bevacizumab biosimilar Vegzelma.

FDA approves pegfilgrastim and rituximab biosimilars

Biosimilars/News | Posted 24/06/2022

The US Food and Drug Administration (FDA) has approved the pegfilgrastim biosimilar Fylnetra (pegfilgrastim-pbbk) and the rituximab biosimilar Riabni (rituximab-arrx).

Byooviz: first ophthalmology biosimilar launches in US

Biosimilars/News | Posted 17/06/2022

Biogen and Samsung Bioepis have launched Byooviz (ranibizumab-nuna) on the US market as the first ophthalmology biosimilar. It references Roche’s (Genentech’s) blockbuster therapy, Lucentis.

Biocon: cancer biosimilar launch in Canada and US$90 million Malaysia deal

Biosimilars/News | Posted 10/06/2022

In May 2022, Biocon Biologics launched a bevacizumab biosimilar co-developed with Viatris (formerly Mylan), in Canada; and in April 2022, Biocon was awarded a three-year contract, worth US$90 million, by Malaysia's Ministry of Health

Canada approves five biosimilars in last seven months

Biosimilars/News | Posted 03/06/2022

Since November 2021, Canada’s drug regulator, Health Canada, has approved no less than five biosimilars for the treatment of diabetes, cancer, osteoporosis and autoimmune conditions.

Lucentis biosimilars approved in the UK and Korea

Biosimilars/News | Posted 27/05/2022

The United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) and South Korea’s Ministry of Food and Drug Safety have approved biosimilar versions of Genentech’s ophthalmology drug, Lucentis (ranibizumab).

New adalimumab biosimilars prepare to launch in Canada, US and Europe

Biosimilars/News | Posted 16/05/2022

Several new adalimumab biosimilar products are preparing to launch in Canada, the US and Europe, from manufacturers including BIOJAMP, Alvotech and Celltrion.

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).

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