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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.

Regulation Europe

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.

Generic Drugs Biosimilars

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.

Biosimilars France
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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.

Generic Drugs Pricing Strategies

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.

Generic Drugs Pricing Strategies

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.

Biosimilars Reimbursement
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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.

Legal Issues Intellectual Property

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.

Sales & Earnings Biosimilars

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.

Generic Drugs Combination Products
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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.

Generic Drugs Pricing Strategies

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.

Market Intelligence Pricing Strategies

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.

Market Intelligence Pricing Strategies
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