Success of Pfizer’s Humira Biosimilar for Rheumatoid Arthritis in Phase III Bodes Well for Its Strong Biosimilar Pipeline
January 23, 2017
By Zalak Naik, BioSpace.com Contributor
Pfizer passed another milestone on January 5 in the immunology space with its robust biosimilar pipeline when the US-based drug giant announced that its Humira biosimilar, PF-06410293, met its primary endpoint in a Phase III trial for rheumatoid arthritis (RA) patients.
Pfizer is seeking to strengthen its position in the biosimilar space with a portfolio of eight total biosimilars at varying stages of development. The drug giant launched Inflectra, a biosimilar version of Johnson & Johnson ’s Remicade in the US in November 2016 and in the EU in February 2015.
The company has five biosimilars in late stage and two in early stage development as of January 2017.
In 2015 and 2016, AbbVie ’s Humira garnered sales of $5,383M and $5,464M, respectively, for RA alone. Humira generated total global sales of $1178.6M at the end of Q3 2016, an increase of 14.5 percent from 2015 sales at the end of Q3. Humira is one of the top selling biologic blockbusters, representing huge opportunity for its biosimilars, the first of which, Amgen ’s Amjevita, was approved in the US in September 2016.
However, due to ongoing patent litigation between AbbVie and Amgen, GlobalData does not anticipate the Humira biosimilar to launch before 2023. Although biosimilars are modified replications of expensive biologic drugs, they are not regarded as generics, as in the case of small molecule drugs. Biosimilars are expensive when compared to generic small molecule drugs; hence, they represent a lucrative market for pharma companies. Moreover, the majority of biologic products are used across various indications, giving pharma companies another reason to invest into these copycat biologics.
Pfizer‘s PF-06410293 belongs to the family of tumor necrosis factor (TNF)-alpha inhibitors. The antibody acts by binding to TNF-alpha and blocking its interaction with the p55 and p75 cell surface TNF receptors. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. TNF-alpha is one of the most important cytokines. It plays a critical role in the cascade of inflammatory reactions. Furthermore, the antibody modulates TNF-alpha-regulated adhesion in the molecules responsible for leukocyte migration.
Pfizer’s PF-06410293 is being evaluated in a multi-national, randomized, double-blind, two-arm, parallel group equivalence phase III trial (REFLECTIONS B538-02) in patients with moderate to severely active RA who have had an inadequate response to methotrexate alone. The trial is aimed at assessing the safety, efficacy, and immunogenicity of PF-06410293 against Humira in combination with methotrexate in 597 patients. Topline trial results suggest that PF-06410293 met the primary endpoint and has demonstrated efficacy comparable to AbbVie’s Humira, as measured by the American College of Rheumatology 20 (ACR20) response rate at Week 12.
PF-06410293 meeting its primary end point in the REFLECTIONS B538-02 trial indicates that Pfizer is on track to strengthen its position in biosimilar space. Pfizer acquired Hospira in September 2015 to boost its biosimilar portfolio. Additionally, Pfizer is utilizing a multichannel approach to position itself in the biosimilars market. The company is focusing on targeting healthcare providers since, with the patients’ consent, healthcare providers make decisions about switching patients from the reference product to its biosimilar. This strategy could help Pfizer secure a better patient share for its currently marketed Remicade biosimilar and future biosimilar products.
Increasing awareness by dedicated field representatives, account managers, and medical advisory board facilitators in hospitals, along with literature and digital assets, are some of the elements of company’s strategy to promote biosimilar use. As the company’s “enCompass” patient assistance program provides copays, reimbursement support, and financial assistance, it is another important way to motivate biosimilar use.
Pfizer believes that its vast biosimilar portfolio and biosimilar-dedicated support structures will encourage healthcare providers in adopting thoughtful biosimilar uptake.
Zalak Naik, MS Pharmacy Practice, is an Immunology Analyst at GlobalData providing expert insights and detailed reports on products in the immunology space with an emphasis on disease market and therapy forecasting. Zalak has four years’ experience in pharmaceutical primary and secondary market research, analytics, and scientific writing.