Biosimilars Update: FDA Panel Voted to Approve Biosimilars for Etanercept & Adalimumab at July Meeting

During the July meeting of the U.S. Food and Drug Administration’s Arthritis Advisory Committee in Silver Spring, Md., the FDA voted to approve two new biosimilars for use by rheumatologists.

Etanercept Biosimilar
GP2015, a proposed biosimilar of etanercept (Enbrel), was evaluated at the FDA‘s Arthritis Advisory Committee meeting.¹ The panel voted unanimously to recommend approval of GP2015.

The treatment’s proposed indications were:

1. Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage and improving physical function in patients with moderate to severe active rheumatoid arthritis (RA) in combination with methotrexate (MTX) or as monotherapy;
2. Reducing signs and symptoms of moderate to severe active polyarticular juvenile idiopathic arthritis in patients aged two years and older;
3. Reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis in combination with MTX in patients who do not respond adequately to MTX alone;
4. Reducing signs and symptoms in patients with active ankylosing spondylitis; and
5. Treating patients 18 years of age or older with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Adalimumab Biosimilar
Additionally, ABP 501, a proposed biosimilar of adalimumab (Humira), was also evaluated at the FDA’s Arthritis Advisory Committee meeting.² The panel voted unanimously to recommend approval of ABP 501.

ABP 501 is an anti-tumor necrosis factor (TNF)-α monoclonal antibody with the same amino acid sequence as adalimumab, as well as the same pharmaceutical dosage form and strength as adalimumab in the U.S. and Europe. The proposed indications were:

1. Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage and improving physical function in adults with moderate to severe active RA as monotherapy or in combination with MTX or other non-biologic, disease-modifying anti-rheumatic drugs (DMARDs);
2. Reducing the signs and symptoms of moderate to severe active polyarticular juvenile idiopathic arthritis in patients aged four years and older as monotherapy or combined with MTX;
3. Reducing the signs and symptoms, inhibiting the progression of structural damage and improving physical function in adults with active psoriatic arthritis as a monotherapy or combined with non-biologic DMARDs;
4. Reducing the signs and symptoms in adults with active ankylosing spondylitis;
5. Treating adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate—only to be administered to patients who will be closely monitored and have regular follow-up visits with a physician;
6. Treating Crohn’s disease with specific parameters; and
7. Treating ulcerative colitis with specific parameters.

The committee reviewed analytical, clinical and pharmacokinetic data from ABP 5101 studies, as well as results from two Phase 3 comparative efficacy and safety studies conducted in both moderate to severe plaque psoriasis and moderate to severe RA patients.³ Primary endpoints in the Phase 3 studies were met, which showed clinical equivalence to adalimumab. Immunogenicity and safety were also comparable to adalimumab. The Biosimilar User Fee Act (BsUFA) target action date of Sept. 25, 2016, was set for this agent.