Policy and Regulation
Regulation Explore this Topic
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EMA Recommends Dozens Of Suspensions Over Flawed Synchron Studies
The EMA’s CHMP has recommended the suspension of marketing authorizations for around 100 generics after identifying “irregularities” in how bioequivalence studies were conducted by Synchron Research Services.

AAM Calls For FTC Scrutiny Of Pharmacy Benefit Manager Practices
Pharmacy benefit managers often fail to encourage the use of generic and biosimilar medications and in fact undermine patient access to these more affordable drugs, the Association for Accessible Medicines has told the US Federal Trade Commission.

Gemme Welcomes Advent Of French Biosimilar Substitution
French off-patent industry association Gemme has welcomed the entry into force of biosimilar substitution – but has protested against recent and ongoing price cuts for small-molecule generics in the context of unprecedented cost pressures.
Pricing Strategies; Reimbursement Explore this Topic
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Germany’s Pro Generika Sees Steep Revlimid Savings
Generic lenalidomide competitors to BMS’ Revlimid brand have brought the cost of the cancer drug down by as much as 60% in Germany just a couple of months after launch, according to local generics association Pro Generika. However, the industry body has warned, price pressure must not grow so pronounced that the generics market becomes unsustainable.

Inflation Impact Must Be Considered During Generics Pricing, Says Canadian Study
Canadian provinces must consider the impact of inflation on generic drugs during the next round of off-patent price setting, says a study from Aviseo and the Canadian Generic Pharmaceutical Association.

Teva: Payers Hold The Cards On Material 2023 Adalimumab Opportunity
Fresh from partner Alvotech resolving patent litigation in the US for its proposed Humira biosimilar, Teva management has detailed the firm’s expectations around the product and the crucial issue of supply.
Intellectual Property Explore this Topic
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Momenta Sues Viatris Over Copaxone Generic – Five Years After Launch
One Copaxone (glatiramer acetate) ANDA sponsor is suing another for alleged patent infringement, with Momenta filing a lawsuit against Viatris and its partners in a US district court.

Celltrion Juggles Biosimilar Market Share As It Shifts To Direct Marketing
Celltrion Healthcare was ultimately able to increase its revenue by 16.7%, with stronger growth expected in H2.

Inhaler Changes For Environmental Reasons Worry Generic Sponsors, Prompt Call For FDA Research
ANDA sponsors say eliminating the HFC propellant, while important to help address climate change, could upend the generic market without guidance from the US FDA.
Market Intelligence Explore this Topic
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Inflation Impact Must Be Considered During Generics Pricing, Says Canadian Study
Canadian provinces must consider the impact of inflation on generic drugs during the next round of off-patent price setting, says a study from Aviseo and the Canadian Generic Pharmaceutical Association.

Solifenacin Surges As UK Sees Huge Price Rises In April
Multiple different generics saw triple-digit-percentage price rises that led UK averages to as much as quadruple in April 2022, according to the latest figures from WaveData. Solifenacin and ibandronic acid led the month’s steepest increases.

UK Pramipexole Prices Plummet In March
Multiple presentations of pramipexole modified-release tablets saw their average UK trade prices nosedive in March, according to the latest figures from market researcher WaveData, which also revealed the reason for the dramatic declines.
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