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Explore This IssueFebruary 2014
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Biosimilars are currently coursing through clinical trials in the U.S. with the hopes of garnering approval by the Food and Drug Administration (FDA) in coming years. At present, Europe is ahead of the U.S. regarding biosimilar guidelines and biosimilar products.1 To-date, 14 biosimilar products for human use have received marketing authorization by the European Medicines Agency (EMA). The European biosimilar guideline was released in 2006, and updates were posted online on October 6, 2013, for a six-month public consultation. Subsequent to this, the guideline will be formally available.
In the U.S., adalimumab is set to lose its patent in December 2016.2 A few manufacturers have already stepped up to develop biosimilars to this blockbuster agent that had annual U.S. sales (in 2012) of more than $9 billion.
- A phase I, double-blind, randomized, parallel-group, single-dose, three-arm study has enrolled healthy volunteers to receive PF-06410293 (Pfizer’s adalimumab biosimilar) compared to U.S. and European sourced adalimumab (Humira) in the REFLECTIONS B-538-01 trial.3 This study aims to show equivalent pharmacokinetic parameters to adalimumab over 43 days. Female and male patients aged 18 to 55 years received 40 mg/0.8 mL administered by subcutaneous injection with a single-use prefilled syringe during the course of this investigation.
- Boehringer Ingelheim’s adalimumab biosimilar, BI 695501, completed a phase I trial involving 193 healthy male subjects aged 18 to 55 years.4 This trial was completed in July 2012; no results have yet been reported, and the status of this investigation is not currently known.5
- Further along in the potential biosimilar approval process is Amgen, with its version of an adalimumab biosimilar, ABP 201.6 ABP-501 is being investigated in a multicenter, randomized, double-blind, active-controlled, parallel-group, 24-week efficacy study in 500 patients aged 18 years and older with moderate to severe rheumatoid arthritis (RA). Equivalent efficacy to branded adalimumab is being evaluated with the ACR20. The study is expected to take 11 months to complete.
- Finally, Sandoz, a division of Novartis that produces generic drugs, has begun a phase III clinical trial of its biosimilar version of adalimumab to demonstrate similarity, equivalent efficacy, and immunogenicity to branded adalimumab in patients with moderate to severe plaque psoriasis.7
Sandoz has also commenced phase III clinical trials for an etanercept biosimilar, GP2015, also to treat moderate-to-severe plaque psoriasis.8 Sandoz may have chosen moderate to severe plaque psoriasis rather than RA to evaluate due to the possibility of being able to better extrapolate psoriasis data to other etanercept indications once approved. The etanercept study is expected to be completed in November 2015, with subsequent U.S. and European regulatory filings.