Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Policy and Regulation

Regulation Explore this Topic

Set Alert for Regulation

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.

Biosimilars Regulation

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.

Generic Drugs Intellectual Property

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.

Biologics Regulation
See All

Pricing Strategies; Reimbursement Explore this Topic

Set Alert for Pricing Strategies and Reimbursement

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.

Generic Drugs Legislation

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.

Biosimilars United States

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.

Biosimilars Pricing Strategies
See All

Intellectual Property Explore this Topic

Set Alert for Intellectual Property

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.

Generic Drugs Intellectual Property

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.

Intellectual Property Legal Issues

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.

Legal Issues Intellectual Property
See All

Market Intelligence Explore this Topic

Set Alert for Market Intelligence

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.

Biosimilars United States

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.

Generic Drugs Biosimilars

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.

Business Strategies Market Intelligence
See All
UsernamePublicRestriction

Register