Policy & Regulation

With the UK generics market facing a rising number of supply issues, local off-patent industry association the BGMA has put forward a raft of policy proposals that it said could provide solutions.

The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.

The proposed CMS innovation center's $2 drug list model will not address the barriers to newer generics getting on Part D formularies and plans may have little incentive to participate in the demo, an industry group said.

Teva has resolved a pair of civil US Department of Justice lawsuits accusing the firm of violating the US Anti-Kickback Statute and the False Claims Act through its alleged conduct conspiring to fix the price of three generic drugs and for allegedly paying Medicare patients’ copays for its multiple sclerosis brand Copaxone.

The US FTC and FDA both received letters from the Senate but with different messaging. One commends for achieved findings and requests a new investigation and another scalds for not doing the assigned job.

Japan has started to charge patients a portion of the difference between the reimbursement price of the generic and non-generic product if they insist on the latter without a supporting recommendation from the prescribing physician, in a policy designed to further drive generic use.

A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.

Generics Bulletin reviews several critical US bills and the off-patent industry’s response, along with budget calculations and new proposals.

Iconovo’s efforts in bringing its Breo Ellipta rival to the market continue, with positive news received from the FDA on the substitutability of the firm’s ICOpre proprietary inhaler. The firm is now seeking a partner to take the product to the next stage.

The US FDA has issued a Form 483 to Granules India, with six observations, spanning document and vent mismanagement to bird droppings and rust.

Generics Bulletin recaps the most recent regulatory news from across the world.

In a closely anticipated US Senate Committee hearing, Novo’s CEO was grilled by US senator Bernie Sanders and others on the high price of Ozempic and Wegovy in the country.

The potential of the UK’s life sciences sector continues to be critically misunderstood and should be the cornerstone of both society and the economy, according to Teva’s CEO Richard Francis.

While senator Coons ensured that the PREVAIL and PERA Acts would not “reverse” already achieved work on drug price reductions, industry players oppose the bipartisan bills, pushing the Senate to vote no.

Pharmacy benefit manager sues Federal Trade Commission, claiming chair Khan has orchestrated a campaign against PBMs that is not based in fact.

In the wake of the Darzi review which set out the stark challenges facing the UK’s National Health Service, local off-patent industry association the BGMA has urged the country’s government to take advantage of a “critical opportunity” to broaden access to medicine while also saving money.

At the recent Morgan Stanley Healthcare Conference in New York, Sandoz leaders set out their views on the significance of – and the FDA’s initial implementation of – the US biosimilar interchangeability designation.

After years of heavy price and cost pressures that have taken a toll on firms operating in the US generics market, more recent quarters appear to have reflected a calmer and more predictable landscape. Generics Bulletin looks at the latest trends.

Generics Bulletin’s editorial team discusses recent conferences held by Medicines for Europe and the AAM, while looking ahead to the key off-patent industry events that are on the calendar over the next few months and beyond.

After UK apixaban prices started to creep up in July, the latest WaveData figures show several different presentations of the generic increasing their average price by multiples in August.