Rheumatology

After years of waiting and legal battles, the first of the 8 adalimumab biosimilars expected to launch in July 2023 have entered the market.

The Center for Biosimilars® provides an updated look on the adalimumab biosimilars that are coming down the US pipeline as well as what stakeholders need to know and how they can prepare ahead of the US launch of 8 adalimumab biosimilars in July 2023.

An analysis of 25 studies found adalimumab, infliximab, and etanercept biosimilars were considered just as safe, effective, and tolerable compared with their originators in the treatment of rheumatoid arthritis.

Coherus Biosciences and AbbVie agree to resolve a dispute regarding Coherus’ partnership with the Mark Cuban Cost Plus Drug Company and an adalimumab biosimilar, and Celltrion and Bio-Thera Solutions expand their respective partnerships to include more biosimilar products.

SmithRx becomes the first pharmacy benefit manager (PBM) to announce it will cover Yusimry, 1 of 9 FDA-approved adalimumab biosimilars; Celltrion Healthcare receives a thumbs-up from the FDA to test a biosimilar for Ocrevus; Alvotech and Teva Pharmaceuticals settle with Johnson & Johnson over their biosimilar referencing Stelara.

A survey of patients with rheumatoid arthritis found that those who had switched to an adalimumab biosimilar reported higher disease severity, poorer treatment adherence, and poorer quality of life compared with patients who stayed on the reference product, highlighting the dangers of the nocebo effect.

Infliximab (IFX) biosimilar SB2 was shown to be safe and effective in IFX-naïve patients and those who switched from a prior IFX reference or biosimilar.

Alvotech and Advanz Pharma extend their partnership to commercialize 5 biosimilar candidates across Europe.

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.

Amgen has settled with Johnson & Johnson (J&J) over the former’s ustekinumab biosimilar referencing Stelara, delaying the projected launch of the candidate from late 2023 to January 2025.

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

As Sandoz and Just-Evotec Biologics announce a new partnership, Celltrion secures tender wins in Italy and Belgium, and Alvotech begins testing its golimumab biosimilar in patients with rheumatoid arthritis.

In light of 2 blockbuster originators, namely Humira (adalimumab) and Stelara (ustekinumab), losing market exclusivity in 2023, 3 doctors penned supplement in The American Journal of Managed Care®. On this episode, Vibeke Strand, MD, one of the co-authors, explored how health systems can take charge and boost biosimilar adoption.

A phase 1 clinical trial in China comparing the tocilizumab biosimilar candidate LZM008 to the reference product (Actemra) found pharmacokinetic (PK) parameters within the bioequivalence margins and similar immunogenicity and safety in healthy participants.

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.

In the first edition of Samsung Bioepis’ Biosimilar Market Report, the company outlined the current state of the US biosimilars market and how increasing adoption has had an impact on pricing changes for biosimilars and their reference products.

In a study including 2 years of real-world evidence (RWE), patients with rheumatoid arthritis (RA) who were switched from originator rituximab (Rituxan) to GP2013, a rituximab biosimilar, experienced positive results and maintained clinical outcomes.

In April, biosimilars to treat rheumatic conditions had some progress, as well as some setbacks, and research showed that switching from originators to biosimilars is safe and effective but warned about the nocebo effect.

Nonmedical switches from Humira (reference adalimumab) to a biosimilar or an adalimumab biosimilar to another biosimilar resulted in nocebo effect responses, suggesting that more communication between providers and patients is needed, according to a real-world analysis.

A recent systematic review looked at the impact of different prices for infliximab in inflammatory bowel disease and the willingness-to-pay threshold around the world.

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.

A retrospective real-world study assessing patient outcomes related to switching from reference rituximab (Rituxan) to a biosimilar version (Truxima) found that transitioning between the products was safe for patients and did not result in a change in adverse events.

The European Union gained another high-concentration adalimumab biosimilar with the approval of Sandoz’ Hyrimoz HCF and the FDA accepted a biologics license application for a trastuzumab biosimilar (HLX02).

Although rheumatologists, dermatologists, and gastroenterologists rated their awareness of adalimumab biosimilars as high, a significant proportion of each group reported that they were not confident prescribing a biosimilar over the originator.

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.

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

Posters presented by Alvotech at 2023 American Academy of Dermatology (AAD) annual meeting showcased proven bioequivalence and therapeutic equivalence candidate biosimilar AVT04 and reference ustekinumab (Stelara).

A review of real-world studies assessing patient-reported outcome measures of patients with rheumatoid arthritis (RA) found that although clinical outcomes were similar, patients taking a biosimilar were found to have higher discontinuation rates, possibly as a result of the nocebo effect.

In the wake of adalimumab biosimilars hitting the US market, Sophia Z. Humphreys, PharmD, MHA, BCBBS, of Sutter Health, hyped up the current biosimilar market trends and the other products coming down the pipeline during her talk at the Festival of Biologics.

At the American Academy of Dermatology annual meeting, Samsung Bioepis shared positive results from a phase 1 study comparing its ustekinumab biosimilars (SB17) with the reference product (Stelara).