Biosimilars
FDA releases new patient guidance on biosimilars
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
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
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
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
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
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
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
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
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
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.
