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Policy and Regulation

Regulation Explore this Topic

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Alvotech Suffers Delay On Higher-Strength Adalimumab In US

Alvotech has suffered a setback in its attempt to gain the first US FDA approval for a higher-strength biosimilar adalimumab rival to Humira, after obstacles preventing facility inspections led the agency to defer action on the firm’s AVT02 candidate.

Biosimilars Regulation

Certara Gets Further FDA Grant For Virtual Bioequivalence Studies

The FDA has awarded biosimulation specialist Certara a further grant to verify and expand models for assessing virtual bioequivalence, to help enable safer, faster and more cost-effective generic drug development.

Regulation Generic Drugs

EU’s Health Emergency Response Plans Must Address Existing Flaws

The EU’s creation of a Health Emergency Response Authority to deal with future health threats has been welcomed by off-patent industry association Medicines for Europe. However, the organization pointed out current policy and regulatory weaknesses that must be addressed if HERA is to be successful.

Policy Regulation
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Pricing Strategies; Reimbursement Explore this Topic

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New Zealand’s Pharmac Mulls Amgevita Listing

New Zealand’s Pharmac pharmaceutical management agency is considering funding Amgen’s Amgevita adalimumab biosimilar rather than the Humira reference brand from early 2022.

Biosimilars Reimbursement

AAM Applauds HHS For Acknowledging Brand-Driven Cost Increases

The AAM has applauded US proposals to lower drug prices, following the development of the HHS’s 45-day plan in response to president Joe Biden’s executive order on promoting competition. However, AAM chief executive Dan Leonard has criticized Congressional proposals to weaken the 180-day incentive for first generics and curtail patent settlement agreements as “misguided.”

Policy Pricing Debate

Timolol Tops UK Price Rises In August

Timolol eye drops saw their prices leap in August while sildenafil’s slide saw prices cut in half, according to the latest UK generics pricing figures from WaveData.

Market Intelligence Pricing Strategies
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Intellectual Property Explore this Topic

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Aurobindo And MSN Labs Join Others In Settling On Allergan’s Fetzima

Two more ANDA companies have reached settlement agreements with AbbVie’s Allergan subsidiary and partner Pierre Fabre Medicament over proposed generic versions of the Fetzima serotonin and norepinephrine reuptake inhibitor.

Generic Drugs Deals

AAM Warns Of Dangerous Precedent In Vascepa 'Skinny Label' Case

By allowing Amarin’s allegation of induced infringement against Hikma over its generic version of Vascepa to proceed, a US court is jeopardizing the ‘skinny label’ system that allows generics to carve out patented indications from their labels under the Hatch-Waxman framework, according to the AAM.

Legal Issues Intellectual Property

Lupin Reaches Quarter-Of-A-Billion Dollar Deal Over Glumetza Antitrust Claims

Lupin has agreed to pay $248m to settle the majority of antitrust claims against the company alleging that it caused and enabled the prolonged delayed launch of generic Glumetza, which subsequently saw a price hike of more than 800% by originator Valeant, now Bausch Health.

Deals Intellectual Property
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Market Intelligence Explore this Topic

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Timolol Tops UK Price Rises In August

Timolol eye drops saw their prices leap in August while sildenafil’s slide saw prices cut in half, according to the latest UK generics pricing figures from WaveData.

Market Intelligence Pricing Strategies

UK Sees Several Triple-Digit Price Rises In July

Ivabradine, lercanidipine, donepezil and aspirin led the steepest price rises seen for UK generics in July 2021, with all of these molecules experiencing triple-digit average increases in certain presentations, according to WaveData.

Market Intelligence Pricing Strategies

June Sees UK Ivabradine Prices More Than Treble

Ivabradine exhibited interesting pricing dynamics in the UK in June, with the average cost of the heart failure treatment more than trebling despite the lowest offer in the market remaining stable.

Market Intelligence Pricing Strategies
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