Policy

The FDA introduced a plan to improve clinical trials, including a provision to possibly eliminate clinical efficacy testing for biologic products, which evidence has suggested may not be necessary, according to Sarfaraz K. Niazi, PhD.

The FDA approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference Stelara (ustekinumab). The biosimilar was also approved with an interchangeability designation.

Panelists at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting chronicled the current state of the US biosimilar market, including current policies impacting the market, recent regulatory decisions, and the developing arguments around requirements for clinical efficacy studies.

The FDA approved Celltrion’s Zymfentra (infliximab-dyyb), a novel drug that allows for subcutaneous administration of inflximab.

Alvotech received a complete response letter (CRL) for its ustekinumab biosimilar; Formycon’s Cimerli, a ranibizumab biosimilar, achieved 25% market share in the United States; and the FDA awarded a researach grant to the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC).

Sarfaraz K. Niazi, PhD, chronicles how drug master files (DMF) can be used in the biosimilar approval process and the role contract development and manufacturing organizations (CDMOs) can play in improving biosimilar accessibility.

Prince Edward Island became the eleventh jurisdiction in Canada to implement a biosimilar transition policy, in which patients who are currently taking select reference agents will transition to biosimilar versions.

An international comparative analysis found that the level of biosimilar market sustainability differs between countries, largely due to variances in biosimilar policies and years of experience managing a biosimilar market.

No safety or immunogenicity differences were found in patients who switched to a biosimilar and those who continued on a reference biologic or biosimilar.

Boehringer Ingelheim (BI) launches an unbranded version of its adalimumab biosimilar; Alvotech and Kashiv Biosciences partner for an omalizumab biosimilar candidate; the FDA issues a complete response letter (CRL) for Biocon’s insulin aspart biosimilar.

Pfizer’s Abrilada (adalimumab-afzb) became the second biosimilar referencing Humira (adalimumab) to receive an interchangeable designation. The new label is intended to expand patient access to biosimilars.

Tofidence, a tocilizumab biosimilar developed by Biogen, will be used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

Sarfaraz K. Niazi, PhD, summarized the citizen petitions he's filed to the FDA as well as changes he believes are needed to propel the biosimilar industry into the future, including calling on biosimilar manufacturers to help.

Nuances in classification for insulin biosimilars can lead to frequent areas of confusion, according to 2 pharmacists.

Drug maker payments to ophthalmologists were associated with the choice of higher-cost therapies for age-related macular degeneration (ARMD) that could increase Medicare costs, but biosimilars could help.

The House Committee members examined pricing tactics by PBMs and how they are harming patients across the country.

In the final part of a 3-part series, Sarfaraz K. Niazi, PhD, gives his take on the FDA's recent workshop dedicated to streamlining biosimilar development and his opinion on what the industry can learn from the webinar presenters.

Growing use of innovator biologics, including those with biosimilar competition, has led to increased Medicare Part B drug expenditures, with the trend unlikely to stop.

An FDA workshop featuring regulators from around the world provided the regulatory perspective on how each government determines whether a biosimilar is clinically equivalent to their reference product, highlighting the science behind their development guidelines.

Perhaps the most significant development in the pharmaceutical industry in decades, crops of biosimilars are being approved and are ready for distribution. What lies next, in terms of legislation and the impact on pharmacists, remains to be seen.

Sarfaraz K. Niazi, PhD, reacts to CMS' list of the first 10 drugs chosen for price negotiation under the Inflation Reduction Act (IRA), including 3 biologics with no biosimilar competition.

Stelara (ustekinumab) and Enbrel (etanercept), 2 originator medications that will face biosimilar competition within the next decade, were among the 10 preliminary drugs chosen for Medicare price negotiation under the Inflation Reduction Act (IRA).

The FDA approved its first biosimilar indicated for multiple sclerosis (MS), Sandoz’ Tyruko (natalizumab-sztn), a biosimilar referencing Tysabi (natalizumab).

Robert Zutaut, RPh, a clinical specialist from McKesson Provider Solutions, quantifies the major barriers to adoption for biosimilars used to treat rheumatoid arthritis (RA) and some major considerations for health systems looking to address them.

The Spanish Psoriasis Working Group updated its position on the use of biosimilar medicines in patients with moderate to severe psoriasis, including its views on biosimilars as first-line treatment and nonmedical switching.

Streamlining biosimilar development would permit biosimilar development of more and a wider variety of biological drugs, fast-tracking biosimilar development without impacting patient safety or effectiveness, according to an opinion piece.

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.

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.