Policy

The Association for Accessible Medicines (AAM) published a white paper on the impact that ongoing drug shortages have had on the generic and biosimilar industries as well as possible solutions stakeholders can put into action.

Sarfaraz K. Niazi, PhD, details his efforts to encourage congressional leaders to draft legislation that would remove interchangeability requirements and animal toxicology studies for biosimilars.

Julie Reed, MS, executive director of the Biosimilars Forum, takes a look at the 3 policy initiatives that could have the greatest ramifications for the US biosimilars industry.

Senator Mike Lee (R, Utah) reintroduced the Biosimilar Red Tape Elimination Act to Congress. The bill aims to get rid of switching study requirements for companies looking to obtain an interchangeability designation for a biosimilar.

Sarfaraz K. Niazi, PhD, flagged an upcoming FDA meeting where stakeholders can make public comment on whether clinical efficacy testing for biosimilars is necessary for regulatory approval.

New research has found the 340B program is slowing uptake of biosimilars by incentivizing use of more expensive biologics.

The Mark Cuban Cost Plus Drug Company, an online pharmacy dedicated to increasing access to lower-cost prescriptions, is partnering with Coherus Biosciences to distribute Yusimry, a biosimilar referencing Humira. It’s the first time the pharmacy has added a biosimilar to its list of drugs.

A group of panelists at Asembia 2023 shared the bigger role that pharmacists, payers, and providers can play in growing biosimilar acceptance and championing policy changes that boost biosimilar utilization.

Celltrion Healthcare announced that the FDA has approved Yuflyma (adalimumab-aaty) as the ninth biosimilar referencing Humira (adalimumab).

Findings from a recent study emphasize the need for improvement and changes regarding follow-on biologics and biosimilars in the global biosimilar market.

Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, discusses how the use of biosimilars in other countries strengthens the acceptance and approval of these products in the United States.

Although the FDA has consistently edited its testing guidelines for biosimilar developers over the years, clinical testing is still very expensive and time-consuming. Sarfaraz K. Niazi, PhD, offers the FDA and companies a plan of action for reducing clinical testing expenses for biosimilar products.

The 2023 Asembia Specialty Pharmacy Summit featured Juliana (Julie) Reed, executive director of the Biosimilars Forum, who spoke on the challenges still facing the biosimilars industry and how they may impact the success of adalimumab biosimilars in the United States.

Sarfaraz K. Niazi, PhD, dives into how pharmacodynamic (PD) markers may be better than clinical efficacy testing for predicting whether a biosimilar is equally as safe and effective as its reference product, in his latest column.

Over the past week, Vegzelma, a bevacizumab biosimilar, launched in the United States; 2 biologics license applications (BLAs) for biosimilars were accepted for review by the FDA; and China’s regulatory agency approved a denosumab biosimilar.

Two US senators introduced a bipartisan bill to extend the $35 out-of-pocket cap for insulin products, established by the Inflation Reduction Act for Medicare plans, to the commercial sector.

A study assessing factors that may determine a commercial health plan’s likelihood of covering a biosimilar found that biosimilars that are cancer therapies, used to treat children, indicated for highly prevalent conditions, or only competing against the originator were more likely to have coverage restrictions.

In a complete response letter (CRL) for Alvotech, the FDA cited “deficiencies” in the company’s manufacturing facility during a reinspection, further delaying the approval for the ninth adalimumab biosimilar until potentially June 2023.

Sarfaraz K. Niazi, PhD, explains and analyzes the FDA's changes for the Biosimilar User Fee Act (BsUFA) meetings and how they influence the efficiency of the biosimilar approval process in the latest installment of his bimonthly column.

On this episode of Not So Different, we discuss some of the global biosimilar policy news that came out during the month of March, including a new bill in Congress and 2 Canadian jurisdictions implementing switching policies.

Policy updates around the world have garnered a lot of attention during March, and suggestions for practices could influence biosimilar adoption and acceptance.

Yukon, 1 of 3 Canadian territories, announced that it will implement a biosimilars switching policy, following Newfoundland and Labrador’s announcement to move forward with a similar policy earlier this week.

The Increasing Access to Biosimilars Act of 2023 (HR 1352), a bill that would direct HHS to establish a demonstration project within Medicare that would establish a shared savings model for biosimilars, was introduced to the House of Representatives.

Newfoundland and Labrador is the latest Canadian province to implement a biosimilar switching policy, following in the footsteps of Ontario and 7 other jurisdictions.

At the Festival of Biologics, Hillel Cohen, the executive director of scientific affairs at Sandoz, shared the current body of literature on biosimilar-to-biosimilar switching, saying that although there isn’t much published data, the vast real-world experience demonstrates the safety of this type of medication switch.

At the Festival of Biologics, Juliana (Julie) Reed, executive director of the Biosimilars Forum, warned that without changes to encourage biosimilar uptake, companies will begin to ask the big question: Are biosimilars worth investing in?

In an article published in Frontiers in Pharmacology, researchers made recommendations to improve the biosimilar regulatory system and refine biosimilar guidelines in China.

In a report from CVS Health, interchangeability will not be a primary factor in driving the adoption of adalimumab biosimilars referencing Humira, contradicting predictions from other sources that believe the designation will impact prescribing habits.

Sarfaraz K. Niazi, PhD, explained why Indian manufacturers aren’t bringing biosimilars to the United States and how FDA policies and procedures discourage global companies from pursuing US market entry.

Better familiarity with biosimilars is enabling government agencies to reevaluate their approval requirements and encouraging smaller manufacturers to invest in biosimilar development, said Michael Kleinrock, lead research director for the IQVIA Institute for Human Data Science.