Biosimilars/General
Biosimilars applications under review by EMA – July 2019
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
South Korea’s Celltrion to sell directly to Australia
In a successful month for Celltrion, the company announces plans to directly sell its anticancer biosimilars in Australia and begins a clinical trial for allergy treatment CT-P39.
NHS England updates its ‘What is a Biosimilar Medicine?’
The National Health Service (NHS) England announced that it had updated its ‘What is a Biosimilar Medicine?’ document in June 2019.
South Korea increases investment in biologicals
Investment in the biotech sector is ramping up in South Korea, with increased state-led support and private sector pledges.
Eli Lilly launches lower-priced insulin lispro
Eli Lilly announced on 22 May 2019 that it had launched the lower-priced authorized biosimilar version of its diabetes treatment Humalog (insulin lispro) in the US.
UnitedHealthcare to prefer brand-name pegfilgrastim
US health insurance provider UnitedHealthcare has announced that it will prefer use of brand-name pegfilgrastim over the biosimilar versions.
Irish hospitals to get incentives to switch patients to biosimilars
Hospitals in Ireland are being offered a Euros 500 incentive for every patient they switch off two expensive biologicals to cheaper biosimilars.
Settlement for Udenyca and win for Zarxio
Amgen has made a settlement with respect to pegfilgrastim biosimilar Udenyca, but has lost its appeal against filgrastim biosimilar Zarxio.
Biocon/Mylan gain global rights to adalimumab biosimilar Hulio
India-based biologicals specialist Biocon and US-based partner Mylan announced on 7 May 2019 that they have gained the global rights to the adalimumab biosimilar Hulio.
Recommendations published by Canadian breast cancer advocacy group
In April 2019, an advocacy group for patients with breast cancer in Canada – the Canadian Breast Cancer Network (CBCN) - published recommendations related to use of biosimilars in a white paper, entitled ‘Breast Cancer & Biosimilars Recommendations on Use, Implementation and Patient Communications’. These recommendations were informed by insights collected from virtual roundtable discussions with patients and medical oncologists.
