Etanercept had U.S. sales of more than $4.2 billion, making it a lucrative biosimilar target, with many potential postapproval indications.9 The following companies all have etanercept biosimilars in clinical development: Biocon/Mylan, Celltrion, Daiichi Sankyo/Coherus Bioscience (CHS-0214), and Mycenax (TuNEX, Phase 3).8-10 The Daiichi Sankyo/Coherus Bioscience (CHS-0214) etanercept biosimilar has shown comparable pharmacokinetics to etanercept in a pivotal clinical study.8 In its current collaborations, Coherus plans on pursuing further etanercept biosimilar development in order to gain approvals in the U.S. and abroad.
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Explore This IssueFebruary 2014
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Other potential biosimilars to rheumatologic products such as rituximab and infliximab are also being sought.2,11 At least one rituximab biosimilar (PF-05280586) is currently in phase II trials.
Pipeline and Drug Approvals
Afrezza, an inhaled form of insulin powder, has been submitted to the FDA for treating types 1 and 2 diabetes mellitus.12 The FDA received the New Drug Application for Afrezza, a drug–device combination, in October 2013. In early 2011, the FDA informed Afrezza’s maker, MannKind, that it needed more efficacy and safety proof using an improved version of the inhaler device (earlier studies used a previous version of the device). The Prescription Drug User Fee Application date is April 15, 2014, and the FDA’s advisory panel will be meeting in advance of that date.
CF101, an oral A3 adenosine receptor (A3AR) agonist, led to ACR20 response by three months in 49% of patients, versus 25% of placebo-treated patients.13 ACR50 and ACR70 improvements were noted in 19% of treated patients, compared to 9% of placebo-treated patients, and 11% of treated patients compared to 3% of placebo-treated patients, respectively. This was a phase IIb study in 79 RA patients who all had elevated A3 adenosine receptor biomarker levels at baseline.
In late December, the FDA approved the first generic of duloxetine (Cymbalta).14 The branded product is FDA approved to treat chronic musculoskeletal pain, fibromyalgia, generalized anxiety disorder, diabetic neuropathic pain, and major depressive disorder.
Dr. Kaufman is a freelance medical writer based in New York City, a pharmacist at New York Presbyterian–Lower Manhattan Hospital, a certified geriatric pharmacist, and adjunct faculty at Touro College of Pharmacy.
- Revised guideline on biosimilars containing biotechnology-derived proteins published for pubic consultation. Published October 6, 2013. www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/06/news_detail_001811.jsp&mid=WC0b01ac058004d5c1. Accessed December 27, 2013.
- Pfizer to start trial for biosimilar adalimumab. Published June 21, 2013. www.gabionline.net/Biosimilars/News/Pfizer-to-start-trial-for-biosimilar-adalimumab. Accessed January 2, 2014.
- Study of PF-06410293 and adalimumab in healthy subjects (REFLECTIONS B538-01). Published January 1, 2014. http://clinicaltrials.gov/ct2/show/NCT01870986?term=to+PF-06410293&rank=1. Accessed January 2, 2014.
- Pharmacokinetics and safety study of BI 695501 in healthy subjects. Published December 12, 2012. http://clinicaltrials.gov/ct2/show/NCT01505491?term=BI+695501&rank=1. Accessed January 2, 2014.
- Boehringer Ingelheim pipeline. Published January 2, 2014. www.boehringer-ingelheim.com/research_development/drug_discovery/pipeline.html. Accessed January 2, 2014.
- Amgen to start phase III trial for biosimilar adalimumab. Published September 27, 2013. http://gabionline.net/Biosimilars/News/Amgen-to-start-phase-III-trial-for-biosimilar-adalimumab. Accessed January 2, 2014.
- Sandoz begins Phase II clinical trials for biosimilar adalimumab. Published December 19, 2013. www.biosimilarnews.com/sandoz-begins-phase-iii-clinical-trial-for-biosimilar-adalimumab. Accessed January 2, 2014.
- Sandoz to start Phase III etanercept trial Published May 24, 2013. http://gabionline.net/Biosimilars/News/Sandoz-to-start-phase-III-etanercept-trial. Accessed January 2, 2014.
- Etanercept biosimilar has comparable pharmacokinetics to Enbrel. Published November 15, 2013. http://gabionline.net/Biosimilars/Research/Etanercept-biosimilar-has-comparable-pharmacokinetics-to-Enbrel/%28highlight%29/coherus%20enbrel. Accessed January 2, 2014.
- Company to pursue next stage of development as part of collaboration with Daiicho Sankyo and Baxter. Published October 29, 2013. www.coherus.com/newsroom/recent-news. Accessed January 2, 2014.
- Walsh N. Biosimilar of Remicade holds up at 2 years. Published October 29, 2013. www.medpagetoday.com/MeetingCoverage/ACR/42551. Accessed January 2 2014.
- White RD. MannKind is seeking approval of diabetes inhaler system by spring. Published December 8, 2013. www.latimes.com/business/la-fi-stock-spotlight-mannkind-20131209,0,7194142.story#axzz2nNJI30ZM. Accessed December 13, 2013.
- Walsh N. Oral RA drug shows promise in early trial. Published December 26, 2013. www.medpagetoday.com/Rheumatology/Arthritis/43582. Accessed December 27, 2013.
- Cassels C. FDA okays first Cymbalta generics. Published December 11, 2013. www.medscape.com/viewarticle/817689. Accessed January 2, 201