Generics
Indivior to appeal US ruling on opioid addiction patent
UK-based addiction treatment manufacturer Indivior Plc have announced plans to appeal against a US court, which ruled that Indian generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) had not infringed patents on their opioid addiction treatment Suboxone.
Generics applications under review by EMA – August 2017
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].
Mylan launches three HIV generics in Canada
US generics giant Mylan Pharmaceuticals (Mylan) announced on 10 August 2017 that it had launched three generic HIV drugs in Canada, after having received final approval for the products from Health Canada.
Teva launches generic testosterone
Teva Pharmaceutical Industries (Teva) has announced the exclusive launch of generic testosterone, previously marketed as Axiron by Eli Lilly and Co, on the US market.
Barriers to generics substitution in the Middle East
Although most pharmacists in Lebanon are in favour of generic drug substitution, fewer than half have actually implemented the policy, according to a study carried out by researchers from the American University of Beirut [1].
FDA receives record number of generic drug applications for 2017
Just part way through 2017, the US Food and Drug Administration (FDA) has already received a record number of generic drug applications, surpassing the totals for both 2016 and 2015.
Generic drug substitution in Lebanon
A new study reports on Lebanon’s recently introduced generic drug substitution and unified prescription policy, a country which spends among the most on pharmaceuticals in the Middle East. The study explored attitudes of community pharmacists towards the idea of the policy and its current implementation [1].
Senior US senator calls on insulin manufacturers to justify high prices
Senator Amy Klobuchar, senior senator from Minnesota, has written to three major diabetes drug manufacturers asking them to justify recent price hikes, which are placing increasing pressure on patients in the US.
Adamis gains FDA approval for its EpiPen rival
Adamis Pharmaceuticals Corporation (Adamis) announced in June 2017 that they have received US Food and Drug Administration (FDA) approval for their EpiPen competitor Symjepi.
WHO prequalifies first generic hepatitis C drug
The World Health Organization (WHO) has prequalified the first generic drug to treat hepatitis C. The antiviral agent sofosbuvir will be manufactured at a lower cost by Mylan.
