Biosimilars

Kimberly Maxfield, PhD, of the FDA discussed actions been taken by the FDA since President Biden's reauthorization of the Biosimilar User Fee Act (BsUFA) III last year, as well as what they plan to achieve through 2027.

Sophia Humphreys, PharmD, MHA, BCBBS, discussed how biosimilars can play a role in formulary management as well as the main takeaways of her presentations at the Newport Beach Institute for Value-Based Care conference.

Jorge Garcia, PharmD, MS, MHA, MBA, FACHE, discussed how infusion therapy can be administered as ambulatory drug infusion and its relation to biosimilars.

HADLIMA is currently indicated for psoriatic arthritis, plaque psoriasis, and hidradenitis suppurativa, among others.

Reporting on the real-world utilization of reference rituximab and its biosimilars can help show prescribing habits and reveal cost-saving opportunities.

Wezlana is the first biosimilar to reference Stelara approved in the United States. The product will launch in 2025.

The ranibizumab biosimilar was the first in ophthalmology to the US market in 2022, but its competition has already had a year of interchangeability exclusivity.

Kimberly Maxfield, PhD, of the FDA reflected upon how the FDA is uplifting the US biosimilar industry.

The results for a proposed aflibercept (Eylea) biosimilar and an accepted ranibizumab (Lucentis) biosimilar were presented at Euretina Congress 2023.

The level of biosimilar market sustainability differs between countries, largely due to variances in biosimilar policies and years of experience managing a biosimilar market.

Biosimilars are becoming more common as more launch on the market in the United States, but patient and provider education can help speed uptake of these products, explained Bincy Abraham, MD, Houston Methodist – Weill Cornell.

Posters presented at the EADV Congress highlighted that despite similar efficacy, patient perception can affect satisfaction with the switch from the reference adalimumab to a biosimilar.

Providers have to know how to manage patients who are hesitant to switch to a biosimilar and payers who have specific preferences about which biosimilar to use.

The FDA has approved Tofidence, the first tocilizumab biosimilar in the United States, which will be used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

Major companies committed to joining Medicare drug price negotiations; Boehringer Ingelheim introduced a low-cost version of its adalimumab biosimilar; schools begin to stock naloxone amid rising opioid deaths among young people.

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

In a few short years, biosimilars have driven down total cost of care in oncology through providing competition for expensive drugs, explained Christine Pfaff, RPh, senior regional director of operations, American Oncology Network (AON).

A survey of gastroenterologists, dermatologists, and rheumatologists found Amjevita had the most recognition, followed by Cyltezo, the only interchangeable biosimilar on the US market.

One-fourth of patients who switched to an infliximab biosimilar retransitioned back to the originator, but they were more likely to subsequently discontinue treatment due to an unwanted response after switching back.

A report from the Association for Accessible Medicines (AAM) highlighted the value of biosimilars and generics, revealing that lower-cost versions of originator products accumulated $408 billion for the US health care system in 2022.

Cordavis is a new subsidiary from CVS Health Corporation that will work with manufacturers to commercialize and coproduce biosimilars, beginning with an adalimumab product.

Drug spending for products facing generic or biosimilar competition decreased during the same time period.

Biosimilars can improve access to treatment for patients who might not have been able to access biologics previously, explained Laura Wingate, executive vice president, Education, Support, & Advocacy, Crohn's & Colitis Foundation.

The Biden administration has released the first 10 drugs subject to price negotiation with Medicare under the Inflation Reduction Act (IRA), and among those chosen were Stelara (ustekinumab) and Enbrel (etanercept), both of which will face biosimilar competition within the next decade.

The FDA has approved the first biosimilar to treat multiple sclerosis, Sandoz's injection treatment natalizumab-sztn (Tyruko).

Greater attention needs to be on educating patients who are switching from a reference product they are successful on to a biosimilar than a patient who is starting a treatment with a biosimilar at the beginning of their disease journey, explained Laura Wingate, executive vice president, Education, Support, & Advocacy, Crohn's & Colitis Foundation.

Amjevita’s revenue was down 63% in the second quarter (Q2) compared with the first quarter of 2023, when the biosimilar launched.

There is a right way and a wrong way to inform a patient about a switch from the reference product to a biosimilar, explained Laura Wingate, executive vice president, Education, Support, & Advocacy, Crohn's & Colitis Foundation.

A white paper crafted by the Association for Accessible Medicines (AAM) outlined that main causes of generic drug shortages and recommended several actions for stakeholders to remedy current shortages and prevent future ones.