General

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].

US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb has once again chastised brand-name drug companies that deliberately delay federal procedures and use regulations to delay the entry of generics competitors.

Kenyan medical insurance management firms are advising that they will only pay for generics and not brand-name prescriptions.

On 16 October 2017, a federal judge in Texas invalidated four key patents for Allergen’s dry eye drug Restasis (cyclosporine ophthalmic emulsion).

Although US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb admits that ‘FDA doesn’t control drug pricing’, he points to the fact that FDA ‘policies do affect competition in the market’. With this in mind he announced on 2 October 2017 ‘a major new set of policies’ aimed at making it easier to bring generic competition to complex drugs.

A deal made between Allergan and a native American tribe could potentially protect the company from challenges on its dry eye drug Restasis (cyclosporine ophthalmic emulsion) and prevent competition from generics in the US.

US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb had announced the creation of a working group of senior staff focused on increasing generic drug competition.

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].

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.

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.