Pricing Strategies and Reimbursement

Generics Bulletin previews the most noteworthy and anticipated events for December 2023.

Dr Reddy’s sees plenty of opportunity in Europe, including for the firm’s burgeoning biosimilars business. However at the same time, current European pricing policies risk exacerbating shortages and are discouraging investment, the firm’s CEO of European operations for global generics, Patrick Aghanian, tells Generics Bulletin in an exclusive interview.

Office of Inspector General analysis could add momentum to reforms of the rebating system.

A fresh UK voluntary pricing scheme for branded medicines has been unveiled that includes differentiated payment mechanisms for older and newer products. However, the BGMA has hit out against aspects of the new deal that it says will provide hurdles for generics and increase the risk of drug shortages.

Four presentations of epilepsy treatment lamotrigine topped WaveData’s table of the fastest-rising prices of typical generics in the UK in October.

With several Humira biosimilars entering the US market, price competition was fiercer and faster than expected in the second half of 2023, according to Cencora. The former AmerisourceBergen firm’s biosimilars experts Brian Biehn and Connor Nell touch on topics including adalimumab trends, ophthalmology and oncology biosimilars, and the Inflation Reduction Act in a Q&A with Generics Bulletin.

Upcoming opportunities facilitated by the EU’s pharma legislation review were highlighted at Medicines for Europe’s fifth annual value added medicines conference, held in Brussels in early November. However, enthusiasm was tempered with acknowledgements that the European sector current lags behind the US and needs further reform to attract investment.

Finance Committee is hoping to attach pharmacy benefit manager reform legislation to end-of-year budget legislation but the prospect is unpredictable at this point.

Now that the first license for a drug has been obtained in partnership with the program, work will begin to ensure other companies that make the product adopt the new licensed indication.

Senate Finance Committee’s PBM legislation would essentially pass through rebate value at the pharmacy counter for some drugs, block situations where beneficiaries pay more than plans and reward biosimilars that have list prices substantially below their reference products.

With large treble-digit-percentage generic price rises scarce in the UK in September, a recently-launched molecule – rasagiline – showed the steepest increase, according to the latest information from market researcher WaveData.

An FDA decision around the timing of first interchangeable biosimilar exclusivity has brought to an end Boehringer Ingelheim’s time on the market with a unique interchangeable Humira rival, with the agency also granting interchangeability for Pfizer’s Abrilada version of adalimumab.

Agency cites possible demonstration in response to HHS Office of Inspector General report urging reimbursement reforms to spur greater use of biosimilars and lower costs for Medicare and beneficiaries.

Boehringer Ingelheim says it is pushing ahead with an earlier than expected launch of a deep-discounted unbranded version of its Cyltezo adalimumab biosimilar in the US, as it looks to compete with other Humira rivals.

A provision in the pending legislation on PBMs that would allow the US FDA to provide qualitative and quantitative information to ANDA sponsors about reference product's inactive ingredients could save hundreds of millions in spending.

With multiple generic molecules experiencing treble-digit-percentage price increases in the UK in August, betahistine tablets led the month’s biggest risers, according to WaveData.