Policy and Regulation
Regulation Explore this Topic
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EMA Clarifies Questions Over Biosimilar Interchangeability
Responding to questions seeking clarifications over a statement on the scientific rationale supporting the interchangeability of biosimilars in the EU, the EMA has issued a supplementary Q&A document to address issues around multiple switches, complexity of molecular structure and national switching policies.

Teva Concedes On US Gimoti ANDA, Voiding 180-Day Exclusivity
Teva will not engage in paragraph IV patent-infringement litigation with Evoke Pharma over the originator’s Gimoti (metoclopramide) nasal spray treatment for diabetic gastroparesis, following a court order.

BsUFA Research Roadmap Highlights Interchangeability And Reducing Trials
The FDA has published a “Research Roadmap” setting out in detail its areas of interest for the agency’s biosimilar regulatory science pilot program under BsUFA III.
Pricing Strategies; Reimbursement Explore this Topic
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US Government Proposals Would Obligate Health Plans To Place Generics On Correct Tiers
The HHS and CMS have proposed that health plans in the US be required to place generic and brand drugs on the correct tiers for their drug category.

Adalimumab Expectations Revised In The Wake Of Amgen Launch
The launch of Amgen’s Amjevita, the first US biosimilar rival to Humira, has been accompanied by multiple fresh forecasts of how competition could play out this year, with a host of further biosimilar launches on the horizon.

Amgen Talks Dual Pricing Strategy For Amjevita
In the wake of Amgen announcing a dual pricing strategy for its debut US adalimumab biosimilar – with the firm’s newly-launched Amjevita version being offered at both 5% off and 55% off the WAC of the Humira original – investors and analysts were keen to press the firm for further details of its pricing strategy.
Intellectual Property Explore this Topic
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Teva Concedes On US Gimoti ANDA, Voiding 180-Day Exclusivity
Teva will not engage in paragraph IV patent-infringement litigation with Evoke Pharma over the originator’s Gimoti (metoclopramide) nasal spray treatment for diabetic gastroparesis, following a court order.

FDA Urged To Collaborate With USPTO On Orange Book Listings, Eliminate Patent Use Codes
Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.

Five Big Legal Stories From 2022
Generics Bulletin looks back at a selection of the most significant legal stories from 2022, including a major victory in the UK on the Eliquis blood thinner giant and continued action on generic label carve outs, which has the potential to reverberate through the US industry.
Market Intelligence Explore this Topic
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Adalimumab Expectations Revised In The Wake Of Amgen Launch
The launch of Amgen’s Amjevita, the first US biosimilar rival to Humira, has been accompanied by multiple fresh forecasts of how competition could play out this year, with a host of further biosimilar launches on the horizon.

Scale Of Off-Patent Savings Ramps Up As Impact Of Biologic LOEs Increases
IQVIA’s latest Global Use of Medicines report demonstrates the impact generics and biosimilars are set to have on global pharmaceutical spending, with losses of exclusivity expected to dampen spending growth over the next five years.

International Trade Groups Call For Regulators To Protect Off-Patent Industry From Inflation
Rising inflation has exacerbated pressures in the off-patent drug sector, prompting Medicines for Europe and the US Association for Accessible Medicines to call for regulatory intervention to ensure the long-term sustainability of the space.
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