The US Food and Drug Administration (FDA) has issued a draft guidance on labelling and advertising of biologicals, including biosimilars.

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 years [1]. This has led to patients rationing their insulin; something that does not happen in other developed countries, but is common in the US.

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 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 plaque psoriasis and will be marketed as Qletli.

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

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.

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

The US drug market receives a new oncology biosimilar as Mylan launches its trastuzumab biosimilar, Ogivri.

Mylan launches anti-cancer biosimilar in the US

The US drug market receives a new oncology biosimilar as Mylan launches its trastuzumab biosimilar, Ogivri.

Joint 26th Medicines for Europe and 23rd IGBA Annual Conference 2020
17‒19 June 2020
Divani Apollon Hotel
Athens, Greece

The US Food and Drug Administration (FDA) announced in February 2020 that it had issued draft guidance on getting approval for biosimilars for just some of the approved indications of the originator biological.