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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 trea...

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 In...

Bill to stop misuse of Citizen Petitions advances in the House Policies & Legislation | Posted 13/12/2019

On 13 November 2019, the House Energy and Commerce’s health subcommittee unanimously advanced a bipartisan bill aimed at preventing companies from using citizen petitions to delay the approval of g...

The impact of generics regulation in Brazil Generics/Research | Posted 13/12/2019

Sales of originator drugs have decreased and the number of generics manufacturers have increased following the introduction of the Brazilian Generics Law, reports a new study [1].

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 pha...

Ontario proposes regulatory changes to simplify drug formulary listing and cut government payments to pharmacies Generics/General | Posted 13/12/2019

Following a number of changes in Canada’s generics and biosimilars landscape in 2019 [1-3], the Ontario Ministry of Health and Long-Term Care (the Ministry) is proposing a number of changes to stre...

FDA issues updated guidance on implementing GDUFA II Guidelines | Posted 13/12/2019

The US Food and Drug Administration (FDA) has revised and replaced its draft guidance on implementing the Generic Drug User Fee Amendments of 2017 (GDUFA II).