Biosimilars

FDA approval for Amgen’s infliximab biosimilar Avsola

Biosimilars/News | Posted 13/12/2019

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

Biosimilars/General | Posted 13/12/2019

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

Biosimilars/News | Posted 13/12/2019

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

Biosimilars/Research | Posted 13/12/2019

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

Biosimilars/News | Posted 06/12/2019

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

Biosimilars/Research | Posted 06/12/2019

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

Biosimilars/News | Posted 06/12/2019

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

EC approval for subcutaneous infliximab biosimilar Remsima SC

Biosimilars/News | Posted 29/11/2019

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

Biosimilars/General | Posted 29/11/2019

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

Biosimilars/Research | Posted 29/11/2019

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.