Legal

The BIOSIM Act would increase the add-on payment for use of a biosimilar, thereby incentivizing practitioners to use these products more often, according to proponents of the bill.

Pay-for-delay settlements between drug companies are better regulated than in the past and are in danger of being overregulated, one panelist said.

Getting to the stage where clinical data on interchangeability are reportable to the FDA is a key milestone in Alvotech’s bid to get its high-concentration adalimumab biosimilar approved and on the market.

A technicality—inability to demonstrate harm—frustrated plaintiffs whose case threatened to sink not just the Affordable Care Act but also the Biosimilars Price Competition and Innovation Act (BPCIA), the pathway for biosimilars approvals.

The Mississippi attorney general takes on major insulin producers and pharmacy benefit managers in a suit alleging a massive pricing scheme to gouge patients and payers.

The European Union makes it far more difficult to obtain patents on biologics, reducing the likelihood of patent “thickets” that stifle competition, the Matrix Global Advisors report states.

Celltrion announces the launch timing for its much anticipated high-concentration formulation of adalimumab and presents trial data supporting equivalence to the reference product.

Biosimilar manufacturers may encounter roadblocks in the months and years ahead, and generics manufacturers will find they've hit a ceiling, according to Adam Fein, PhD, CEO of the Drug Channels Institute.

Accused of unfair trade practices, AbbVie's CEO Richard Gonzalez pointed the finger at Medicare Part D.

The House Committee on Oversight and Reform contends AbbVie's "biosimilar defense strategy" has succeeded beyond the company's wildest imagination.

Originator company Amgen has won another round in defending its lucrative etanercept franchise, but the decision is sure to intensify scrutiny of extended patent protections.

When it comes to biologics, there is a constant push and pull over patent rights. Some believe this is part of a healthy market-driven economy. Others are skeptical.

After being sued for allegedly stealing adalimumab process information, Alvotech fires back.

Intellectual property attorneys from Axinn discuss the limitations of the Purple Book patent disclosure requirements and the burden these impose on biosimilar developers.

The anatomy of an interchangeability switching study.

Representative Carolyn B. Maloney, D-New York, questions the use of pharmaceutical profits to defend against biosimilar competition.

How much muscle did Congress invest in a pair of bills recently signed by President Biden? The answer may lie in your willingness to believe.

More disclosures, earlier in the biosimilar application process, might lead to more competition in biologics, but panelists said this could go too far.

US senators hope to spread the word about biosimilars and limit product exclusivity protections to those products that truly deserve them.

Opinions are diverse on how best to clear the obstructions to biosimilar market entry and patient access.

The latest e-book from The Center for Biosimilars® offers insightful content on patient education, biosimilar development, and regulatory issues.

The company claims in a suit that a former employee transferred high-concentration adalimumab trade secrets to his laptop and took those to a new job with Alvotech.

"Shocked" by the threat of competition, originator manufacturers start raising prices long before rival products appear on the scene, investigators found.

The Biologics Price Competition and Innovation Act has been around for 10 years, but grey legal areas still abound, Goodwin attorneys note.

Minnesota legislators introduce what could possibly become the first law to curtail payers' rights to determine which biologics patients have access to.

Huiya Wu, JD, and Freddy Yip, PhD, PCLL, attorneys at Goodwin Procter, discussed biologic drug patent laws in China and the US.

Under the Biden administration, the Department of Justice (DOJ) has reversed course and now backs the constitutionality of the Affordable Care Act (ACA).

Authors of a new study conclude that artificial intelligence could improve the selection of biosimilars for therapy.

Incremental gains in the number of approved biosimilars and no new biologic categories were the low points, but uptake and improved patient access were highlights of 2020.

Intellectual property law attorneys from Axinn discuss regulatory and legal events in 2020 that will affect biosimilar markets in 2021.