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FDA issues draft guidance on labelling and advertising of biologicals Guidelines | Posted 21/02/2020

The US Food and Drug Administration (FDA) has issued a draft guidance on labelling and advertising of biologicals, including biosimilars.

Reasons and solutions for the high cost of insulin in the US Biosimilars/Research | Posted 21/02/2020

The most commonly used forms of analogue insulin cost 10 times more in the US than in any other developed country. In fact, the cost of insulin in the country has more than tripled in the past 10 y...

Merck to create spin off for women’s health and biosimilars Pharma News | Posted 21/02/2020

US pharma giant Merck is to create a spin-off company for its women’s health, biosimilars and legacy products, allowing the main company to focus on blockbuster cancer drug Keytruda (pembrolizumab).

Bio-Thera launches first adalimumab copy biological in China Biosimilars/News | Posted 21/02/2020

Bio-Thera Solutions (Bio-Thera) announced in January 2020 the launch of the first adalimumab copy biological in China. The drug can be used to treat rheumatoid arthritis, ankylosing spondylitis and...

US-Mexico-Canada agreement to benefit generics makers Policies & Legislation | Posted 21/02/2020

The amended United States-Mexico-Canada Agreement (USMCA) will benefit biosimilar and generic drug companies through changes to patent protection for originator drugs.

EMA recommends four new generics Generics/News | Posted 21/02/2020

At the Committee for Medicinal Products for Human Use’s (CHMP) January 2020 meeting, the Committee recommended four new generics, and one new biosimilar, for approval.

Russian drug shortages at ‘crisis point’ Generics/General | Posted 21/02/2020

Russia has been facing limited access to foreign pharmaceutical products for several years, but recent reports suggest drug shortages are reaching ‘crisis point’.

Mylan launches anti-cancer biosimilar in the US Biosimilars/News | Posted 21/02/2020

The US drug market receives a new oncology biosimilar as Mylan launches its trastuzumab biosimilar, Ogivri.Mylan launches anti-cancer biosimilar in the USThe US drug market receives a new oncology...