Biosimilars

Clinical data requirements for biosimilars in the EU: efficacy comparability

Biosimilars/Research | Posted 08/11/2019

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

Biosimilars/News | Posted 08/11/2019

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

Biosimilars/Research | Posted 25/10/2019

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

Biosimilars/News | Posted 25/10/2019

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

Biosimilars/Research | Posted 25/10/2019

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

Biosimilars/Research | Posted 18/10/2019

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

Biosimilars/News | Posted 18/10/2019

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

Biosimilars/General | Posted 18/10/2019

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

Biosimilars/Research | Posted 18/10/2019

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

Biosimilars/Research | Posted 11/10/2019

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

Biosimilars/News | Posted 11/10/2019

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

Biosimilars/News | Posted 11/10/2019

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).

FDA releases new patient guidance on biosimilars

Biosimilars/General | Posted 11/10/2019

The US Food and Drug Administration (FDA) has released new patient materials on biosimilars, which explain that biosimilars are as safe and effective as their reference biological and answer a number of commonly asked questions.

Adalimumab copy biological shown to be safe and effective

Biosimilars/Research | Posted 11/10/2019

Chinese biopharmaceutical firm Innovent Biologics’ adalimumab copy biological has shown comparable safety and efficacy to the originator drug, Humira (adalimumab), in patients with ankylosing spondylitis.

Biosimilars applications reviewed in the EU

Biosimilars/Research | Posted 04/10/2019

The European Union (EU) was the first to establish a legal framework for biosimilars back in 2003 [1]. Since the European Medicines Agency (EMA) approved its first biosimilars in 2006, the agency has issued new guidelines and updated its existing guidelines based on new evidence and rapid advances in analytical sciences [2].

Three darbepoetin alfa biosimilars approved in Japan

Biosimilars/News | Posted 04/10/2019

Three pharmaceutical companies have announced approval of their anaemia treatments for sale on the Japanese market, while Mochida reveals it will sell the first teriparatide biosimilar in the country.

Novo Nordisk to launch biosimilar insulin in the US

Biosimilars/General | Posted 04/10/2019

Novo Nordisk has announced plans to launch biosimilar versions of its NovoLog and NovoLog Mix insulin products in the US in January 2020.

iBio and CC-Pharming collaborate for rituximab copy biological in China

Biosimilars/News | Posted 04/10/2019

Biotechnology company iBio, self-professed leader in the plant-made pharmaceutical field, announced on 27 August 2019 that it will expand its collaboration with China-based CC-Pharming for a rituximab copy biological in China.

Switching from originator to biosimilar epoetins appears to be effective and safe

Biosimilars/Research | Posted 04/10/2019

Switching between biological drugs during pharmacological treatment leads prescribers and patients to ask themselves the question: ‘Will it be safe?’. In particular, when switching from an originator to a biosimilar, the belief that this choice is shaped by economic reasons feeds suspicions and controversies.

Positive EMA-CHMP opinion for SC infliximab biosimilar

Biosimilars/News | Posted 27/09/2019

South Korean biotechnology company Celltrion announced on 22 September 2019 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended for approval the company’s subcutaneous (SC) formulation of its infliximab biosimilar (CT-P13) in patients with rheumatoid arthritis (RA).

Mylan’s insulin biosimilar blocked, but wins patent battle over pegfilgrastim biosimilar

Biosimilars/General | Posted 27/09/2019

Mylan has received a second complete response letter (CRL) from the US Food and Drug Administration (FDA) over its Lantus biosimilar, while a US District Court rules in their favour over their pegfilgrastim biosimilar, Fulphila.

Samsung Bioepis to supply Brenzys to Brazil under production development partnership

Biosimilars/News | Posted 27/09/2019

On 10 September 2019, Samsung Bioepis announced that it had signed a productive development partnership (PDP) with Brazil’s Ministry of Health to supply Brenzys, a similar biotherapeutic product to rheumatoid arthritis treatment Enbrel (etanercept), to Brazil for the next 10 years.