Biosimilars

Biocad announces positive rituximab results and plans to enter EU market

Russian biotechnology company Biocad has announced plans to enter the European market and has published positive results for its rituximab non-originator biological Acellbia (BCD-020).

Positive trial results for Lannett’s insulin biosimilar

US firm Lannett has completed a successful trial of their candidate insulin biosimilar, which was compared to Sanofi’s blockbuster insulin product Lantus.

NeuClone progress with ustekinumab and trastuzumab biosimilars

Australian biosimilars firm NeuClone has started a phase I trial of their proposed ustekinumab biosimilar and announced positive results from a trial of their trastuzumab biosimilar.

Non-originator biologicals approved in Russia

Last update: 10 January 2020

In Russia, the regulatory body for the approval of medicines is Russia’s Ministry of Health (Министерство здравоохранения Российской Федерации; Rosminzdrav, Minzdrav).

Analytical similarity assessment of teriparatide biosimilar Terrosa

Terrosa and Movymia (both developed under the code name RGB-10), were the first biosimilars of Eli Lilly’s osteoporosis biological Forteo/Forsteo (teriparatide) in Europe. Gedeon Richter and Stada Arzneimittel gained European Commission approval for Terrosa and Movymia in January 2017 [1] and launched the biosimilars in August 2019 [2]. Meanwhile, RGB-10 was also approved in other countries, including Switzerland and Japan.

FDA approval for Amgen’s infliximab biosimilar Avsola

US-based biotech giant Amgen announced on 6 December 2019 that it had received approval from the US Food and Drug Administration (FDA) for its infliximab biosimilar Avsola (ABP 710).

Canadian gastroenterologists issue biosimilar position statement

The Canadian Association of Gastroenterology (CAG) and Crohn’s and Colitis Canada announced on 24 October 2019 that they had issued a joint position statement on the use of biosimilars for the treatment of inflammatory bowel disease (IBD) [1].

Bio-Thera gains Chinese approval for adalimumab copy biological and starts ustekinumab trial

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has approved Qletli, an adalimumab copy biological. The NMPA has also approved the Investigational New Drug (IND) application from Bio-Thera Solutions (Bio-Thera) to initiate a phase I clinical study for the proposed ustekinumab copy biological BAT2206.

Pharmacists must be ready to take the lead on biosimilars

Pharmacists should take the lead in increasing the adoption of biosimilars in clinical practice, says a review of the implications of biosimilars for pharmacy practice. The review suggests that pharmacists in all settings can take a key role in advocating for biosimilars [1].

Australia approves five biosimilars since June 2019

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) has approved five biosimilars since June 2019. The biosimilars approved in the country since then include three pegfilgrastim biosimilars, a trastuzumab biosimilar and a bevacizumab biosimilar.

Use of pegfilgrastim copy biological Mecapegfilgrastim in neutropenia

Italian oncologists report on studies carried out with a new pegfilgrastim copy biological, Mecapegfilgrastim (HHPG-19K) [1].

Phase III trials started for bevacizumab and natalizumab biosimilars

Phase III trials have started for proposed biosimilars of bevacizumab and natalizumab.

EC approval for subcutaneous infliximab biosimilar Remsima SC

South Korean biotechnology company Celltrion Healthcare (Celltrion) announced on 26 November 2019 that it had received European Commission (EC) approval for the subcutaneous (SC) formulation of its infliximab biosimilar (CT-P13) in patients with rheumatoid arthritis (RA).

WHO launches insulin prequalification programme

The World Health Organization (WHO) has announced a pilot prequalification scheme to certify biosimilar versions of insulin in order to increase supply in low- and middle-income countries.

Biosimilar education for Canadian nurses

In general, Canadian nurses are familiar with biosimilars. However, according to authors Sehdev et al., they may have knowledge gaps in their specific understanding, resulting in a significant unmet need for education.

Lupin to launch etanercept and pegfilgrastim biosimilars in the US

India-based generics maker Lupin, which is expecting European approval for its etanercept biosimilar in March 2020, has announced plans to launch the drug on the US market soon after, alongside a pegfilgrastim biosimilar.

FDA approves adalimumab biosimilar Abrilada

US-based pharma giant Pfizer announced on 18 November 2019 that it had received approval from the US Food and Drug Administration (FDA) for its adalimumab biosimilar (PF 06410293).

Qilu starts phase III trial for denosumab copy biological

Chinese pharmaceutical company, Qilu Pharmaceutical (Qilu) is carrying out a phase III clinical trial for a copy biological of Amgen’s Prolia/Xgeva (denosumab).

Brazilian efficacy and safety data for biosimilar infliximab CT-P13 in the treatment of psoriasis and psoriatic arthritis

Celltrion/Hospira’s infliximab biosimilar Remsima/Inflectra (CT-P13) was authorized by the European Medicines Agency (EMA) in 2013 [1] and by the US Food and Drug Administration (FDA) in 2016 [2].

Biologicals and biosimilar use in Asian patients with IBD

The increasing incidence of inflammatory bowel diseases (IBD) has become a major challenge for gastroenterologists in some Asian countries, particularly China, Japan and Korea. This subject was discussed in the August 2019 issue of the Journal of Gastroenterology and Hepatology [1].

Adalimumab copy biological accepted for review in China

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for the approval of adalimumab copy biological UBP1211.

Oncology pharmacists issue position statement on biosimilars

On 4 October 2019, the International Society of Oncology Pharmacy Practitioners (ISOPP) issued their global position on the use of biosimilars in cancer treatment and supportive care.

Phase I trials started for aflibercept and ustekinumab biosimilars

Phase I trials have started for proposed biosimilars of aflibercept and ustekinumab.

South Korean biologicals company Alteogen has, according to clinicaltrials.gov, started a phase I trial for its candidate aflibercept biosimilar ALT-L9.

Samsung reveals positive trial results for bevacizumab biosimilar, but admits to failure with rituximab

A phase III trial of Samsung Bioepis’ bevacizumab biosimilar has shown equivalence to reference drug Avastin (bevacizumab). However, the company has admitted to failures in its attempt to develop a rituximab biosimilar at a recent trial in the Seoul Central District Court.

FDA approves pegfilgrastim biosimilar Ziextenzo

Sandoz, the generics division of Novartis, announced on 5 November 2019 that it had received approval from the US Food and Drug Administration (FDA) for its pegfilgrastim biosimilar Ziextenzo (LA-EP2006).

Clinical data requirements for biosimilars in the EU: immunogenicity comparability

The totality of evidence approach for biosimilars in the European Union (EU) was discussed in a review paper [1] using case studies to illustrate biosimilars for which differences were observed in different parts of the comparability exercise and the justification for why these differences did not preclude regulatory approval.

Tanvex BioPharma’s filgrastim biosimilar comes under fire

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) is having a rough time lately. In July 2019, Amgen filed an infringement lawsuit against the company regarding its filgrastim biosimilar, TX01. Then in September 2019, US Food and Drug Administration (FDA) rejected Tanvex’s application for approval of TX01.

Biosimilars regulation in Canada: state of play

A paper recently published in GaBI Journal provides an update on the regulation and reimbursement of biosimilars in Canada, including changes to the regulation on switching and processes for private plan reimbursement [1].

Clinical data requirements for biosimilars in the EU: efficacy comparability

The European Medicines Agency (EMA) uses a totality of evidence approach in its regulatory review process for biosimilar approval. As part of this, the biosimilar should demonstrate that it does not have clinically meaningful differences from the originator biological, based on comparative clinical studies.

Bevacizumab ‘similar biologic’ Versavo launched in India

India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 19 August 2019 that it had launched its bevacizumab ‘similar biologic’, Versavo (DRZ_BZ) in India.

Clinical data requirements for biosimilars in the EU: PK and PD comparability

In their article [1], authors from the Paul-Ehrlich-Institut, the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), discussed the totality of evidence approach for biosimilars in the European Union (EU) using case studies to illustrate biosimilars for which differences were observed in different parts of the comparability exercise and on the justification for why these differences did not preclude regulatory approval.

EMA approval for Pegfilgrastim Mundipharma

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 18 October 2019 that it had recommended granting of a marketing authorization for the pegfilgrastim biosimilar Pegfilgrastim Mundipharma.

Positive real-world data for etanercept biosimilar Benepali

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 9 October 2019 that it had presented positive real-world data from its etanercept biosimilar Benepali at the 2019 European Academy of Dermatology and Venereology (EADV) Congress [1].

Clinical data requirements for biosimilars in the EU: analytical comparability

For biosimilars, the regulatory review process is based on the totality of evidence generated in support of biosimilarity.

Russian approval for non-originator dornase alfa

Russian biotechnology company Generium and Swiss-based cell-line producer Selexis announced on 17 September 2019 that the Russian Ministry of Health had approved their dornase alfa non-originator biological drug, Tigerase. The drug is a non-originator biological of Roche’s Pulmozyme (dornase alfa).

Celltrion and Juno make biosimilars deal in Australia and Herzuma launches in Iraq

South Korean biotechnology company Celltrion Healthcare (Celltrion) has entered into a partnership with Juno Pharmaceuticals (Juno) to market the trastuzumab biosimilar Herzuma and rituximab biosimilar Truxima in Australia. The company also launched Herzuma in Iraq.

Trial of bevacizumab copy biological with novel antibody targeting PD-1

China-based Shanghai Henlius Biotech (Henlius) is recruiting patients for a study that will investigate a proposed bevacizumab copy biological in combination with a novel antibody targeting PD-1.

Clinical data requirements for biosimilars in the EU

In their article [1], authors from the Paul-Ehrlich-Institut, the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) discussed the clinical data requirements for biosimilars in the European Union (EU).

FDA approves Pfenex’s follow-on teriparatide product

US-based biotech firm Pfenex announced on 7 October 2019 that it had received approval from the US Food and Drug Administration (FDA) for its follow-on teriparatide product (PF708).

Biocon/Mylan launch first insulin glargine biosimilar in Australia

India-based biologicals specialist Biocon and US-based partner Mylan announced on 3 October 2019 the launch of the first insulin glargine biosimilar in Australia available on the Pharmaceutical Benefits Scheme (PBS).