Generics
Pharmacopeial standards may increase generics competition
Pharmacopeias, which contain descriptions of drug preparations, are critical for ensuring the safety of drug products. A study from Johns Hopkins University has now shown that pharmacopeial standards may also increase generics competition [1].
Delayed entry of buprenorphine generics cost NHS England GBP 0.5 million
A market analysis has shown that lack of competition for generic buprenorphinepatches meant the National Health Service (NHS) in England lost savings. The analysis estimates that if all generic drug products entered the market at the same time, the NHS could have saved GBP 0.5 million more over a six-month period [1].
Chinese company makes copy of patented coronavirus treatment remdesivir
China’s BrightGene has successfully produced remdesivir, an experimental treatment for coronavirus, however, patents for the drug are currently held by the American company Gilead.
Survey reveals attitudes to unauthorized hepatitis C generics
A survey of physicians, pharmacists, patients and other professionals in Switzerland has shown that, although most people think unauthorized generics are lower quality than their corresponding brand, they do support their import for those in need [1].
US lawmakers question FDA on complex generics approvals
A US Congress Committee have sent a letter to the US Food and Drug Administration (FDA) regarding concerns over the approval of complex generics.
EMA recommends four new generics
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’
Russia has been facing limited access to foreign pharmaceutical products for several years, but recent reports suggest drug shortages are reaching ‘crisis point’.
Irish pharmaceutical association urges political parties to create a new medicines policy
The Irish Pharmaceutical Healthcare Association (IPHA) has urged political parties to mandate new policy to increase access to medicines ahead of the Irish general election, which was held on 8 February 2020.
Generics applications under review by EMA – January 2020
Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].
FDA approves generics for cancer and gout
The US Food and Drug Administration (FDA) has approved two generic versions of Novartis’ anticancer drug Afinitor (everolimus), alongside a generic of Takeda’s gout treatment Uloric (febuxostat).
