The generic and biosimilar company Sandoz, a Novartis (NYSE:SIX) subsidiary, has received FDA approval for its Humira biosimilar Hyrimoz (adalimumab-adaz) injection. AbbVie’s (NYSE:ABBV) megablockbuster Humira is a biologic medication with indications for an array of autoimmune conditions, including rheumatoid arthritis, Crohn’s disease and psoriasis. Sandoz’s biosimilar will likely be priced significantly lower than Humira’s. This fact could dramatically impact the marketplace for AbbVie’s version of the drug, as it is priced lower and could lead to a decrease in market share for Humira.

The FDA approved Sandoz’s Hyrimoz, a biosimilar of AbbVie’s Humira, to treat seven conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

It scored its first FDA approval on December 31, 2002, for rheumatoid arthritis. 

Sandoz plans to launch the product in the U.S. on July 1, 2023.

Earlier this month, the company announced plans to invest $400 million in biomanufacturing facilities in Slovenia. 

The adalimumab biosimilar market is poised to grow at an annual rate of 24%, according to Data Bridge Market Research. 

Background on adalimumab

Adalimumab has been a cash cow for AbbVie. First approved in 2002 under the brand Humira, adalimumab generated $21.24 billion in revenue in 2022, accounting for roughly 37% of AbbVie’s total net revenues. 

AbbVie CEO Rick Gonzalez said in the company’s Q4 2022 earnings call that the company planned on dealing with growing adalimumab biosimilar competition for extending the indications for the monoclonal antibody Skyrizi (risankizumab) is a monoclonal antibody and the Janus kinase (JAK) inhibitor Rinvoq (upadacitinib). The new indications would span “all of Humira’s major indications, plus a distinct new indication, atopic dermatitis,” Gonzalez said. “We anticipate these two products will collectively exceed the peak revenues achieved by Humira by 2027, with significant growth expected through the end of the decade.” Gonzalez also noted that the company was increasing its portfolio of heme and solid tumor candidates for oncology. 

AbbVie believes it is well-placed to deal with the impact of the Humira loss of exclusivity and return to “robust sales growth” in 2025, Gonzalez added. 

Impact on the marketplace

Analysts project that Humira biosimilars could save patients and payers billions of dollars each year.

AbbVie is now facing biosimilar competition for adalimumab in Europe and the U.S. The availability of a biosimilar version of adalimumab in the U.S. could potentially have a significant impact on the marketplace for AbbVie’s version of the drug. In Europe, Sandoz is pricing Hyrimoz at €1,144.65 for two prefilled pens or syringes at 40 mg or €3,354.43 for a pack of six. Its price is 21% lower than Humira’s. 

Amgen’s (Nasdaq:AMGN) Amjevita (adalimumab-atto) was the first biosimilar to Humira to win FDA approval. The company plans on introducing Amjevita this year. 

Adeleke Badejo, a senior immunology analyst at GlobalData, highlights some challenges newer treatments face. “With the loss of first-in-class status, newer treatments must not only overcome the natural assurance healthcare providers have acquired with established treatments but also navigate the obstacle of generics and biosimilars within the drug class,” Badejo said. He also observed that the presence of generic biologics might disproportionately affect new therapies.

Using Amgen’s Amjevita as an example, Badejo notes that its launch is a significant event within the Crohn’s disease and inflammatory bowel disease market. But Badejo concludes that the biosimilars may not have a substantial impact on AbbVie’s market position, given the company’s moves to make Rinvoq and Skyrizi “apparent heirs for Humira within immunology.”

Other competitors

Mylan’s (Nasdaq:MYL) Ixifra is another Humira biosimilar. It could hit the market in the European Union this year as well. 

Additionally, MiGenTra is also developing a biosimilar adalimumab candidate, and the first participants in a Phase 1 clinical trial have been dosed. The trial received unconditional approval from the Paul-Ehrlich Institut (PEI) and is being conducted in Germany.

The approval of Sandoz’s Hyrimoz and the development of MiGenTra’s biosimilar candidate are just two examples of the growing biosimilar market. As the biosimilar landscape evolves, patients, healthcare providers, and payers alike can expect increased competition and potentially more accessible treatment options for various conditions.

---

Filed Under: Drug Discovery and Development, Gastroenterology, Rheumatology
Tagged With: AbbVie, adalimumab, Amgen, atopic dermatitis, biologics, biomanufacturing, biosimilar, biosimilars, Crohn's disease, generic, Humira, Hyrimoz, psoriasis, rheumatoid arthritis, sandoz
 

---