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Can The Pipeline Soothe A US Generics Pricing Headache?

Diversified Businesses Provide Sustainability After Challenges Of 2021

 
• By Dean Rudge

Following a year marked by aggressive pricing pressures weighing down on revenues and margins – pressures that “intensified beyond historical norms and our recent expectations,” as one company put it – the first quarter of 2022 provided some green shoots of optimism, albeit for companies that have been able to shift resources to more complex assets.

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Pricing issue dominates in the US • Source: Shutterstock

After several years of relative price stability for US generics companies, following the painful fallout from the most recent cycle in 2016-17 that rocked manufacturers big and small, the thorny issue of pricing pressure began to rear its head again last year.

“A lot of that’s being driven because of volume declines we saw in Q1,” observed Sandoz Inc. head Richard...

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Cigna Claims BMS Tied Revlimid Settlements to Pomalyst ‘Pay-for-Delay’ Scheme

 
• By Dean Rudge

Among other schemes, Cigna alleges that Celgene and parent Bristol Myers Squibb “paid” generic challengers – via lucrative Revlimid profit-sharing agreements – to delay generic market entry for Pomalyst until 2026, unlawfully extending their monopoly and overcharging purchasers.

US Supreme Court Requests Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking a brief “expressing the views of the United States,” following the US Federal Circuit’s decision to reopen Amarin’s claim of induced infringement against Hikma relating to its ‘skinny-label’ generic Vascepa (icosapent ethyl) product.

Viatris Targets Gilead’s Odefsey HIV Blockbuster In Europe With CHMP Recommendation

 
• By Dean Rudge

Viatris has secured two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use for generics to two blockbusters: Gilead’s HIV drug Odefsey and Boehringer’s IPF treatment Ofev, with a path to approvals possible in 67 days.

AAM Celebrates Court Backing Over Minnesota Pricing Law

 
• By Dave Wallace

The AAM has welcomed a US appeals court decision backing an injunction against a Minnesota state law on drug pricing, following an earlier favorable district court ruling.

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Biocon Agreement Provides Multiple Oncology Biosimilars To Malaysian Cancer NGO

 
• By Dean Rudge

Biocon Biologics will look to combine its “scientific expertise with the National Cancer Society of Malaysia’s strong community outreach and patient support network,” after signing striking up a partnership with the NGO providing for supply of three biosimilars.

Cigna Claims BMS Tied Revlimid Settlements to Pomalyst ‘Pay-for-Delay’ Scheme

 
• By Dean Rudge

Among other schemes, Cigna alleges that Celgene and parent Bristol Myers Squibb “paid” generic challengers – via lucrative Revlimid profit-sharing agreements – to delay generic market entry for Pomalyst until 2026, unlawfully extending their monopoly and overcharging purchasers.

US Supreme Court Requests Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking a brief “expressing the views of the United States,” following the US Federal Circuit’s decision to reopen Amarin’s claim of induced infringement against Hikma relating to its ‘skinny-label’ generic Vascepa (icosapent ethyl) product.