Biosimilars/News

Biosimilar launches in Canada and US: Byooviz and Stimufend

Biosimilars/News | Posted 31/03/2023

In Canada, Biogen announced that their Byooviz (ranibizumab) injection, a biosimilar of Lucentis, is available as of March 2023. In the preceding month, Fresenius Kabi launched Stimufend (pegfilgrastim-fpgk), a biosimilar of Amgen’s Neulasta, in the US.

EMA recommends approval of eculizumab biosimilar Bekemv

Biosimilars/News | Posted 23/03/2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 24 February 2023 that it had recommended granting of marketing authorization for the eculizumab biosimilar Bekemv.

China approves tocilizumab copy biological BAT1806

Biosimilars/News | Posted 16/03/2023

In January 2023, Bio-Thera Solutions announced that the China National Medical Products Administration (NMPA) approved BAT1806, a biosimilar of Actemra (tocilizumab), in China. This is the world’s first tocilizumab copy biological/biosimilar to be approved.

FDA accepts application for denosumab biosimilar GP2411

Biosimilars/News | Posted 09/03/2023

Sandoz, the generics division of Novartis, announced on 6 February 2023 that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for a proposed denosumab biosimilar (GP2411).

EMA accepts application for ustekinumab biosimilar AVT04

Biosimilars/News | Posted 03/03/2023

Alvotech announced on 9 February 2023 that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT04, their proposed biosimilar to Stelara (ustekinumab).

Ranibizumab biosimilar Ximluci and Amelivu to launch in the UK and South Korea

Biosimilars/News | Posted 24/02/2023

STADA and Xbrane Biopharma have announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorization for Ximluci, a biosimilar referencing ophthalmology drug, Lucentis (ranibizumab). In addition, Samsung Bioepis and Samil Pharmaceuticals will launch their biosimilar of Lucentis, Amelivu, in South Korea.

New indication for Cosentyx (secukinumab) biological: hidradenitis suppurativa

Biosimilars/News | Posted 19/05/2023

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use adopted a positive opinion on 26 April 2023 recommending Novartis' Cosentyx (secukinumab) to treat active moderate to severe hidradenitis suppurativa (HS) in adults.

Advances for Henlius’ trastuzumab and bevacizumab biosimilars in the US

Biosimilars/News | Posted 20/04/2023

The US Food and Drug Administration (FDA) accepted Henlius' application for HLX02 (biosimilar trastuzumab for injection). Meanwhile, Henlius' multicentre phase III clinical trial (NCT04740671) of HLX04-O (biosimilar bevacizumab) for wet age-related macular degeneration (wAMD) commenced in the US with the first patient dosed.

First African developed biosimilar adalimumab starts phase I trial in Germany

Biosimilars/News | Posted 06/04/2023

A phase I clinical trial of Minapharm Pharmaceuticals’ first African developed adalimumab biosimilar, Adessia, was initiated on 24 February 2023 in Germany with results to be expected at the end of 2023.

Bevacizumab biosimilar Vegzelma approved and Aybintio launched in Canada

Biosimilars/News | Posted 10/02/2023

The bevacizumab biosimilar Vegzelma produced by Celltrion received full label approval from Canada’s drug regulator, Health Canada (HC), on 3 January 2023. Back in November 2022, bevacizumab biosimilar Aybintio by Samsung Bioepis had been launched in Canada by Organon, offering a more affordable treatment for Canadian patients suffering from certain types of aggressive cancer.

Advances for Alvotech’s partnerships in Japan, Canada and Switzerland

Biosimilars/News | Posted 18/11/2022

In October 2022, Alvotech announced new advances with partners Fuji Pharma in Japan and JAMP in Canada. In addition, in September 2022, with its partner STADA, Alvotech announced the launch of Hukyndra, its high-concentration, low-volume, citrate-free formulation, biosimilar to Humira (adalimumab), in Switzerland.

Progress for Lucentis (ranibizumab) biosimilars in Europe and the US

Biosimilars/News | Posted 28/10/2022

On 16 September 2022, Partners Stada Arzneimittel and Xbrane Biopharma announced that the European Medicines Agency’S (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Ximluci, a biosimilar candidate referencing Lucentis (ranibizumab). In addition, on 19 September 2022 in the US, Coherus BioSciences announced that from 3 October 2022, another ranibizumab biosimilar, Cimerli (ranibizumab-eqrn) will be commercially available.

Advances for adalimumab biosimilars in Saudi Arabia, Europe and Canada

Biosimilars/News | Posted 17/02/2023

In January 2023, Alvotech-Bioventure, Sandoz and Samsung Bioepis announced advances for their adalimumab biosimilars in Saudi Arabia, Europe and Canada, respectively.

New insulin glargine and potential adalimumab interchangeable biosimilars

Biosimilars/News | Posted 27/01/2023

The US Food and Drug Administration (FDA) awarded Eli Lilly’s Rezvoglar, an insulin glargine biosimilar, the interchangeable designation in late 2022. This means that in the US, Rezvoglar can now be substituted at the pharmacy level for the originator, Sanofi’s Lantus, without a doctor’s prescription, provided state pharmacy law permits the switch. In addition, a study revealed that Pfizer’s adalimumab biosimilar may also soon achieve this status.

Biosimilar advances for Alvotech-Teva and setback for Biocon Biologics

Biosimilars/News | Posted 20/01/2023

Alvotech and Teva Pharmaceuticals announced in January 2023, that the US Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab). Meanwhile, Biocon Biologics received a complete response letter (CRL) from FDAregarding its application for an insulin aspart biosimilar (filed by its partner Viatris).

Advances for Bio-Thera’s secukinumab and mepolizumab copy biologicals

Biosimilars/News | Posted 13/01/2023

China’s Bio-Thera Solutions announced in November 2022 that dosing has begun in a phase III clinical study for BAT2306, a proposed copy biological of arthritis anti-inflammatory treatment, Cosentyx (secukinumab). In addition, the company also recently announced a phase I clinical study to compare the pharmacokinetics and safety of BAT2606, a proposed copy biological of asthma treatment, Nucala (mepolizumab), to US-sourced and EU-sourced reference product in normal healthy volunteers.

FDA and EMA file acceptance of Biogen’s tocilizumab biosimilar

Biosimilars/News | Posted 12/12/2022

Biogen announced on 9 December 2022 that the US Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (BLA) for BIIB800, a biosimilar candidate referencing Roche’s Actemra/RoActemra (tocilizumab); and on 30 September 2022 that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application for BIIB800.

Canada approves etanercept biosimilar Rymti

Biosimilars/News | Posted 01/12/2022

The etanercept biosimilar Rymti, produced by Lupin, received approval from Canada’s drug regulator, Health Canada (HC), on 13 September 2022, for all indications of the reference product Enbrel. This is the third etanercept biosimilar to receive approval in Canada [1].

Australia and EU: Alvotech Humira and Stada Lucentis biosimilars approved

Biosimilars/News | Posted 25/11/2022

In November 2022, Alvotech announced that the Therapeutic Goods Administration (TGA) of Australia has granted marketing authorization for its a high-concentration low-volume adalimumab, AVT02, a biosimilar referencing Humira and marketed by their partner, Cipla Australia. In addition, Stada Arzneimittel and Xbrane Biopharma announced that the European Commission granted marketing authorization for their Ximluci (ranibizumab), a biosimilar candidate referencing Lucentis.

Bevacizumab biosimilar approvals and launch in Japan and USA

Biosimilars/News | Posted 21/10/2022

On 27 and 28 September 2022, Celltrion announced that its oncology biosimilar bevacizumab, Vegzelma, has been approved in Japan and the US. In October 2022, Amneal Pharmaceuticals, also announced the launch of Alymsys (bevacizumab-maly) in the US.

Forwards for Formycon’s Keytruda and backwards for Prestige’s Herceptin

Biosimilars/News | Posted 14/10/2022

On 19 September 2022, Formycon announced details of a project to produce a biosimilar of Keytruda (pembrolizumab). This followed news that, on 16September 2022, Prestige Biopharma withdrew the Marketing Authorization Application (MAA) for their Herceptin Biosimilar, Tuznue, submitted to the European Medicines Agency (EMA).

FDA approves biosimilar pegfilgrastim Stimufend

Biosimilars/News | Posted 06/10/2022

On 6 September 2022, Fresenius Kabi announced that they had received approval from the US Food and Drug Administration (FDA) for their pegfilgrastim biosimilar, Stimufend (pegfilgrastim-fpgk).

EC approves bevacizumab biosimilar Vegzelma

Biosimilars/News | Posted 23/09/2022

On 18 August 2022, South Korea-based biologicals specialist Celltrion announced that its bevacizumab biosimilar, Vegzelma (CT-P16), had received European Commission (EC) approval.

FDA accepts application for high concentration adalimumab biosimilar

Biosimilars/News | Posted 16/09/2022

Sandoz, the generics division of Novartis, announced on 21 July 2022 that the US Food and Drug Administration (FDA) had accepted the supplemental biologics license application for the high concentration formulation (HCF) of its adalimumab biosimilar Hyrimoz (GP2017) (adalimumab-adaz).

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).