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Non-innovator biologicals in India: regulatory context and areas for improvement Biosimilars/Research | Posted 04/05/2020

There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality b...

Biocon/Mylan launch pegfilgrastim biosimilar Fulphila in Australia Biosimilars/News | Posted 04/05/2020

US-based drugmaker Mylan and partner India-based biologicals specialist Biocon have announced the launch of their pegfilgrastim biosimilar, Fulphila, in Australia. The drug can be used to treat neu...

Biosimilars could have saved US companies US$1.4 billion in 2018 Reports | Posted 04/05/2020

Increasing the use of biosimilar could have saved self-insured companies in the US up to US$1.4 billion on just two biologicals – infliximab and filgrastim – during 2018.

Five key questions about the ‘patent dance’ answered Policies & Legislation | Posted 04/05/2020

Law firm Fish and Richardson have provided answers to five key questions for biosimilar makers when it comes to the patent dance.

New information on biosimilars from Australia and the US Biosimilars/General | Posted 04/05/2020

The Generic Biosimilar Medicines Association and the Biologics Prescriber Collaborative have released new information on biosimilars, aimed at physicians and the public, respectively.

FDA issues guidance on hydroxychloroquine, chloroquine Guidelines | Posted 04/05/2020

The US Food and Drug Administration (FDA) has released new guidance on hydroxychloroquine and chloroquine, which have been raised by President Trump as treatments for coronavirus, despite limited e...

Clinical trials for adalimumab biosimilar SB5 Biosimilars/Research | Posted 04/05/2020

The clinical trials used to support the approval of Samsung Bioepis/Merck’s adalimumab biosimilar SB5 (Imraldi/Hadlima), were critically reviewed by authors from Argentina and the UK, with a specia...

CMS proposes new measures to rate generic usage Generics/General | Posted 04/05/2020

The Centers for Medicare & Medicaid Services (CMS) is actively working to promote competition and lower costs for drugs, according to a statement released in February 2020, which also details n...