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By John T. Aquino
Jan. 26 — The FDA Jan. 25 accepted for review Amgen's application for a biosimilar of Humira (adalimumab), which could increase competition in the autoimmune disease market if it's approved, the company said.
Humira is the top-selling drug at AbbVie Inc., with 2014 global sales of $12.3 billion and estimated global sales of more than $18 billion by 2020, according to AbbVie's forecast. It's licensed to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, hidradenitis suppurativa, adult and pediatric Crohn's disease and ulcerative colitis.
Only one biosimilar has been approved by the Food and Drug Administration—Sandoz's Zarxio, a biosimilar of Amgen's cancer treatment Neupogen, in March 2015 (9 LSLR 328, 3/20/15).
A biosimilar is seen as cutting into the market share of the reference product for which it is biologically similar. Bloomberg Intelligence analysts wrote that Humira sales could drop once a biosimilar is approved, but the severity is uncertain and the drop could be delayed by possible AbbVie court action.
A biosimilar is a large-molecule, complex biologic product that is approved based on a showing that it is highly similar to and has shown no clinically meaningful differences in terms of safety and efficacy from an already-approved biological product, known as a reference product.
Under the Biologics Price Competition and Innovation Act (BPCIA), a biosimilar can take an abbreviated approval pathway utilizing the data of the reference product. The abbreviated pathway can reduce the development cost and therefore the sales price.
Sandoz's Zarxio biosimilar is selling for 15 percent less than Amgen's reference product Neupogen (9 LSLR 24, 12/11/15). In Europe, where biosimilars have been on the market for a number of years, the discounts have ranged from 20 percent to 30 percent (see (9 LSLR 459, 4/17/15).
Amgen's biosimilar is named ABP 501. The company submitted a biologics license application (BLA) on Nov. 25, 2015 (9 LSLR 24, 12/11/15). The FDA's decision is expected by Sept. 25.
Amgen's role as a biosimilar applicant is a turnaround because it has been the reference product sponsor for other companies' biosimilars of Neupogen (filgrastim)—Zarxio, Neulasta (pegfilgrastim), Epogen (epoetin alfa) and Enbrel (etanercept).
Sean E. Harper, Amgen's executive vice president of research and development, said in a statement, “If approved, we believe ABP 501 could serve as an important additional approved therapeutic option for patients with chronic inflammatory conditions. We look forward to potentially expanding our robust portfolio of approved products and further demonstrating our continued commitment to delivering high-quality medicines to patients worldwide.”
ABP 501, if approved, could hurt AbbVie.
According to Sam Fazeli, Bloomberg Intelligence's senior industry analyst, AbbVie's dependence on Humira, which accounted for 63 percent of sales in 2014, exposes it to potential biosimilars starting in 2017 after the patents covering Humira expire in 2016.
However, given the example of the 15 percent discount for Zarxio and the track record for European biosimilars of 20 percent to 30 percent reductions, the impact on Humira sales likely won't be as significant as the 70 percent to 90 percent discounts generics bring compared with brand-name, small-molecule drugs.
In addition, under the BPCIA, the reference product sponsor and the BLA applicant may exchange information including what is called the “patent dance,” in which Amgen would give AbbVie the names of patents that the Humira biosimilar could infringe. This would help AbbVie to decide whether or not to file a patent infringement action against Amgen and carefully target any litigation.
Fazeli wrote that if AbbVie files an infringement lawsuit, which could happen in 2016 if AbbVie chooses not to engage in the “patent dance” or in 2017 if it does, the legal fight could extend well into 2020. That could keep the biosimilar off the market until then, provided AbbVie wins an injunction from the court.
And while the patents covering Humira expire in 2016, Amgen's patent portfolio includes secondary patents for anti-TNF antibodies such as Humira, formulations and crystalline forms that have expirations as far out as 2034, according to Bloomberg Intelligence analyst Aude Gerspacher.
AbbVie has been fighting to protect its market share by actions such as filing a citizen petition with the FDA on BPCIA interpretations (10 LSLR 01, 1/8/16)
For its part, Amgen attempted to challenge the validity of two of AbbVie's patents covering Humira with petitions for inter partes review with the Patent and Trademark Office's Patent Trial and Appeal Board. The PTAB denied both petitions on Jan. 14.
According to Amgen, the BLA is based on analytical, clinical and pharmacokinetic data. Phase III comparative efficacy and safety studies were conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.
The phase III studies met their primary endpoints, showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab, the company said.
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