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The MHRA’s premarket statutory instrument for Great Britain should to be laid before UK parliament in Q2 and be in force by year end, in an ideal world. There are concerns that the new statutory instrument must align with imminent EU MDR changes.
Propranolol prices that were almost five times higher in November meant that the beta-blocker topped our table of UK price rises this month, as ciprofloxacin prices also continued to climb.
International reliance mechanisms for approving drugs have an important place, but the UK regulator should increase focus on becoming a first approver of medicines, according to the British pharmaceutical industry.
Under the newly-announced UK-US trade deal, the UK will increase the thresholds used to evaluate the cost-effectiveness of new medicines, which should allow higher prices for innovative therapies.
Generics Bulletin reviews global regulatory developments across the world.
With UK chancellor Rachel Reeves set to deliver the country’s budget on Wednesday, Medicines UK has set out five “focus areas” where the off-patent industry believes that action is needed.
With UK chancellor Rachel Reeves set to deliver the country’s budget on Wednesday, Medicines UK has set out five “focus areas” where the off-patent industry believes that action is needed.
Sandoz has heralded the onset of biosimilar competition to Eylea in Europe with the launch of its Afqlir version. Meanwhile, the firm has also struck up a further ranibizumab alliance with Formycon in Germany.
UK ruling clears the way for Alvotech to stockpile its aflibercept biosimilar ahead of Eylea’s SPC expiry later this month, positioning the firm for a day-one launch across Europe and the UK.
UK SMEs complained about the proposed 2025-2027 MHRA user fees and got easements on payments for trials and scaled-back registration and PMS service fees. Now the agency is offering more assistance in a pilot of clinical trial fee waivers.
Henlius and its commercial partner Organon further break ground with a third denosumab biosimilar approval this year.
As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.