Bulgaria should remove clawback taxes for generics and biosimilars, avoid external reference-pricing mechanisms, adopt measures to drive up generic prescribing and adopt a “dynamic” biosimilars policy to encourage uptake, European off-patent industry association Medicines for Europe has urged. The industry body has also called on the new European Commission to offer the country its support in these areas.
Action must be taken in Bulgaria to bolster the country’s generics and biosimilars market, according to European off-patent industry association Medicines for Europe.
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Generics Bulletin reviews global regulatory developments across the world.
The US Senate Judiciary Committee’s Chairman Chuck Grassley criticized the Senate’s reduced working hours as six previously introduced bills once again land on their desk.
Henlius has reported progress in its development of a bevacizumab product for treating ophthalmic diseases, with its Essex-partnered HLX04-O candidate meeting its primary endpoint in a Phase III trial. Meanwhile, Outlook Therapeutics has taken another shot at getting its own ophthalmic bevacizumab approved in the US after resubmitting its filing.
While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.
Henlius has reported progress in its development of a bevacizumab product for treating ophthalmic diseases, with its Essex-partnered HLX04-O candidate meeting its primary endpoint in a Phase III trial. Meanwhile, Outlook Therapeutics has taken another shot at getting its own ophthalmic bevacizumab approved in the US after resubmitting its filing.
While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.
Four key areas for policy reform were identified by industry association Medicines for Europe at its biosimilars conference in early April, as sector chair Isabell Remus set out the importance of removing barriers to biosimilar competition.
