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.

A round-up of European consumer health business news: Dermapharm sees 2021 sales rise on the back of increased vitamin D demand; Sanofi plans to launch Enzymatica's ColdZyme in Turkey; and Slovenia's Krka posts rise in OTC sales.

A round-up of the latest consumer health appointments: Germany's Klosterfrau names sales director; Probi hires R&D vice president; and GSK appoints two country managers.

Turkish medtechs’ demands for payment of their outstanding hospital debts went unheeded in 2021, but the government has finally started a payment process. It is not evenly applied, and has started in a small way, but the industry feels encouraged on more than one count.

2021 witnessed a landmark event in May when the new Medical Device Regulation first applied. The medtech sector will experience a similar milestone this year with the new IVD Regulation coming into force in some four months' time. Medtech Insight reflects on the broad and complex swathe of changes that took place in 2021, putting industry under considerable pressure, and predicts no let-up this year.

Amid delays in surgical operations caused by shortages of equipment and medtech companies demanding payment of outstanding hospital debts, a strong devaluation of the Turkish lira has put the local health care system on a crisis footing.

Late payment of hospital debts continues to haunt the Turkish medtech industry, which recently led a public demonstration in Ankara to focus the government’s attention on the issue. Medtech multinationals fear that the ongoing problems will mean Turkey losing the positive momentum it achieved during the pandemic.

Keeping up with the huge volume of work coming out from European bodies intended to support the implementation of the Medical Device and IVD Regulations is industry’s latest challenge.

Alignment with the MDR gave Turkish medtech access to the EU market, but in domestic pricing, costs, reimbursement and payment of hospital debts, industry might feel it is barely at the starting line.

26 May marked the end of the EU medical device directives. In the run up to this date and the full initiation of the Medical Device Regulation, strong views were expressed about the new system as new documents and implementation tools emerged.

Turkey and the EU have avoided the equivalent of a Brexit, or Swixit. Medtech trade will continue unhindered now it has been established that the EU/Turkey Customs Union will remain.