Turkey

A round-up of the latest European consumer health appointments: Haleon hires new CFO; Bayer Vital names new chief; Abdi Ibrahim appoints consumer health head.

A round-up of the latest appointments in Europe's health and wellness industries: Bayer Consumer Health promotes Schellnock to CFO; Germany's BPI elects Kirst as chairman; and DocMorris CEO Hess takes on leadership of the firm's German operation.

Five years after striking a biosimilars alliance with Iceland’s Alvotech, Turkish firm Abdi İbrahim – which boasts the country’s “largest biotech pharmaceutical manufacturing facility” – has shaken hands with Spanish developer mAbxience for technology transfer of an undisclosed oncology biosimilar.

There are now 41 notified bodies in total under the EU’s Medical Device Regulation.

“Maturity level 3” signifies that Türkiye now has a “stable, well functioning and integrated” regulatory system.

CDER manufacturing quality director notes origin of Food, Drug and Cosmetic Act in 1938 is linked to DEG/EG poisoning. FDA says current outbreak in at least seven countries “one of the largest epidemics of DEG and EG poisoning in history.”

Alvotech has signed an agreement with Polifarma to distribute its proposed aflibercept biosimilar in Turkey. The compound, AVT06, is currently in the development stage.

Korean developer Dong-A has signed an exclusive licensing deal with Turkey’s Polifarma covering its darbepoetin biosimilar version of Aranesp/Nesp in Turkey, Brazil and Mexico.

The devaluation of the Turkish Lira since May is making imports of medical devices more expensive and putting hospital procurement under renewed pressure. The local medtech industry associations TUMDEF and ARTED describe the problems  ̶  and the solutions  ̶  to Medtech Insight.

As the COVID-19 pandemic wore on, industry clamored for the US FDA to re-inspect troubled drug manufacturing plants remotely if need be to clear them for new approvals. Now FDA investigators are out in force and early returns from Sun, Aurobindo, Lupin and Sterling suggest these re-inspections will be as tough as ever.