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Australia approves three biosimilars in first half of 2019

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) has up until the end of June 2019 approved three biosimilars. The biosimilars approved in the country so far include two trastuzumab biosimilars and an adalimumab biosimilar.

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.

Dramatic price reduction of trastuzumab in Malaysia

The price of the cancer drug trastuzumab has dropped by more than half in Malaysia following a recent tender to the Ministry of Health.

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.

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