Legal

The year 2021 brought several firsts in biosimilars and set the stage for expansion across therapeutic areas including diabetes and ophthalmology.

After an unsuccessful attempt to get an Illinois court to block the distribution of Alvotech's adalimumab candidate, AbbVie has tried again in a new forum.

Xbrane Biopharma of Stockholm, Sweden, said its next biosimilar candidates will target the demand for oncology and hematology therapeutics.

Ahead of sales and revenues, Icelandic company Alvotech lines up a massive capital investment and an initial public offering (IPO).

Steven Yates, MD, an oncologist and medical director at Intermountain Healthcare, discusses problems underlying the 340B Drug Pricing Program.

In the second setback this year for etanercept biosimilars, the US District Court for the District of New Jersey has ordered Samsung Bioepis to delay marketing Eticovo until 2029.

Authors of a review discuss barriers to insulin access and potential solutions as the 100-year anniversary of the drug's first use for diabetes gets closer.

Sarah Yim, MD, provided a point-by-point overview of the FDA's efforts to clarify the role of the interchangeable biosimilar designation, improve communication with manufacturers, and pay for biosimilar regulatory reviews.

As House leaders sought to build support for the Build Back Better Act, the Association for Accessible Medicines (AAM) objected to drug price negotiations and proposed “rebate penalties.”

Kicking off Global Biosimilars Week, the International Generic and Biosimilar Medicines Association (IGBA) released a blueprint detailing hurdles and opportunities for industry progress.

The second interchangeable biosimilar approval, estimates of biosimilar savings, and competition for ranibizumab biosimilars characterized the month's developments.

The interchangeable designation allows pharmacists more flexibility to dispense this potentially money-saving product and gives Boehringer Ingelheim a marketing edge.

A US District Court in Illinois has ruled that although trade secret theft may have occurred over an adalimumab biosimilar candidate, it happened far from the state. With only a very "attenuated" connection, there are no grounds to bring action against Alvotech in the case of purloined manufacturing data, the judge stated.

The court battle between AbbVie and Alvotech could be a defining victory in the struggle to bring biosimilar versions of adalimumab to market, but a yearlong court process must play out first.

The Center for Biosimilars® Advisory Board member Sarfaraz K. Niazi, PhD, explains an “against the grain” approach to tapping unmet need and revenue potential in biosimilars.

In a biosimilar trend report, Amgen discusses marketing achievements, US biosimilar policy, payer and provider acceptance of these agents, and the outlook for further growth.

The “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA) is meant to resolve litigation efficiently, and it does, although in practice biosimilar developers and originator companies may not completely adhere to the prescribed steps, according to Biotechnology Innovation Organization (BIO) experts.

The findings support Alvotech's bid for interchangeable status for the high-concentration, citrate-free adalimumab biosimilar candidate.

The strength of a patent wall built up around an originator biologic depends on the quality of patents that make it up and the originator company's willingness to engage in costly litigation. Part 2 of a series.

In this first part of a series, intellectual property attorneys from the Biotechnology Innovation Organization (BIO) contend that originator patents are not the formidable obstacles to biosimilars they are made out to be.

The Biologics Price Competition and Innovation Act (BPCIA) provides a stepwise approach for fact-finding prior to patent litigation, but companies may choose their own path, case examples show.

Without disclosing terms, Pfizer said it has settled with Johnson & Johnson (J&J) over a long-running dispute in which J&J was alleged to have blocked payers from covering Inflectra.

Amgen's advertising appeared to push doctors and patients away from the prefilled syringe version of its pegfilgrastim (Neulasta) product, which may have a better sales future than the Onpro.

Panelists at the American Conference Institute's 2021 meeting took on the complexities of biosimilar adoption in a wide-ranging discussion.

Medicare lost out on over $2 billion in savings as adalimumab biosimilars were sidelined by patent restrictions, said investigators who recommended patent reforms.

Following the release of a whitepaper on sustainable generics and biosimilars markets, members of a trade association discussed concerning trends for the industry.

The Center for Biosimilars® provided news and insight during June 2021 in the form of interviews with key opinion leaders and coverage of major events. Catch up on what you missed.

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.