Semler

• A number of medicines for use in the EU rely on studies carried out at the Semler site in India. The studies, called 'bioequivalence' studies, are usually the basis for approving generic medicines.
• The bioequivalence studies performed at the Semler site have been found to be flawed, so they cannot be relied on. As a result, several medicines approved in the EU have been suspended.
• The list of medicines recommended for suspension.
• National authorities in the EU will consider how critical individual medicines are in their countries and make final decisions on whether to suspend or allow them to remain available, while new data are generated.
• There is currently no evidence of unexpected harm or lack of effectiveness with any medicine approved on the basis of studies conducted at Semler.
• Generic medicines containing abacavir/lamivudine (used to treat HIV), which were approved on the basis of studies conducted at Semler, can remain on the market in the EU. This is because during this review, alternative studies from different sources were provided that show bioequivalence.
• Medicines still under evaluation cannot be granted authorisation in the EU on the basis of studies conducted at Semler; further data would have to be provided to support authorisation.
• Medicines that have been suspended can have their suspension lifted if the companies provide alternative data demonstrating bioequivalence.
• Patients should continue to take their medicines as prescribed and contact their doctors in case of questions or concerns.

The review covered medicines authorised via national procedures in individual EU Member States, whose marketing authorisation applications included data from Semler's bioanalytical site (Semler Research Center Private Ltd, 75A, 15^th Cross, 1^st Phase, JP Nagar, Bangalore 560 078, Karnataka, India) and from Semler's clinical site (PA Arcade, #21, 22, 23, Kodigehali Main Road, Sahakaranagar Post, Bangalore 560 092, Karnataka, India).

It also included ongoing marketing authorisation applications for medicines which use study data from these sites. No generic medicine authorised centrally via EMA was tested in these sites.

Semler is a contract research organisation (CRO) with an analytical and a clinical site located in Bangalore, India. These sites conduct the analytical and clinical parts of bioequivalence studies, some of which are used to support marketing authorisation applications of medicines in the EU. The Semler site also performs bioequivalence studies for some medicines authorised in the US and medicines included in the WHO prequalification programme.

The review of Semler was initiated on 28 April 2016 at the request of Denmark, Germany, the Netherlands, Spain and the United Kingdom under Article 31 of Directive 2001/83/EC.

The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's opinion. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 22 September 2016.