PF-06410293 met primary endpoints during clinical trials and demonstrated similar efficacy to its reference product.
Results from a REFLECTIONS B538-02 trial with Pfizer’s investigational Humira (adalimumab) biosimilar, PF-06410293, showed that the drug met its primary endpoint, and demonstrated similar efficacy to its reference product. PF-06410293 is being evaluated in combination with methotrexate as a treatment for moderate to severe rheumatoid arthritis, the company said in a Jan. 5, 2017 announcement.
PF-06410293 is Pfizer’s second proposed inflammation biosimilar. The company’s pipeline consists of eight biosimilar molecules in mid- to late-stage development. Pfizer also said it has several other biosimilar molecules currently in early-stage development. Pfizer will likely face competition in the Humira biosimilar market. FDA approved the first biosimilar to Humira, Amjevita (adalimumab-atto), marketed by Amgen in the United States, in late September 2016.
Source: Pfizer
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.