Amgen (AMGN) announced that AmgevitaTM, a biosimilar to adalimumab, will launch in markets across Europe beginning on October 16, 2018.
According to Amgen’s press release, AmgevitaTM is the first adalimumab biosimilar to be approved by the European Commission (EC). The EC approval is based on analytical, pharmacokinetic and clinical data, including results from two Phase 3 confirmatory studies of the product for moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. The Phase 3 studies met their primary endpoint showing no clinically meaningful differences from adalimumab. The safety and immunogenicity of Amgevita were comparable to adalimumab, and the data included a double-blind randomized switch from adalimumab to Amgevita. Moreover, Amgevita was also evaluated in a long-term Phase 3 study in moderate-to-severe rheumatoid arthritis, demonstrating that the efficacy was maintained with no new safety findings.
Sold currently around the world under the brand name Humira. Adalimumab has become a giant, bestselling product as it is prescribed for a large number of inflammatory diseases. They include autoimmune diseases and rheumatic joint diseases.
In adults: the product is prescribed for: moderate-to-severe rheumatoid arthritis, psoriatic arthritis, severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate-to-severe chronic plaque psoriasis, moderate-to-severe hidradenitis suppurativa, non-infectious intermediate, posterior and panuveitis, moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis.
In pediatrics: the product is authorized for: moderate-to-severe Crohn’s disease (ages six and older), severe chronic plaque psoriasis (ages four and older), enthesitis-related arthritis (ages six and older) and polyarticular juvenile idiopathic arthritis (ages two and older).
David M. Reese, M.D., Executive Vice President of Research and Development at Amgen said, “The launch of Amgevita in Europe is an important milestone for our biosimilars portfolio, expanding the range of treatment options for the millions of patients living with chronic inflammatory diseases.” Dr. Reese remarked, “Amgevita is Amgen’s second biosimilar to launch in Europe, demonstrating our commitment to providing patients with serious illnesses access to high-quality biological therapies.”
Amgevita will launch in the 28 countries that are members of the European Union as well as in Norway, Iceland and Liechtenstein, which are members of the European Economic Area.
Amgevita is a fully human immunoglobulin G1 monoclonal antibody that binds and neutralizes human tumor necrosis factor alpha (TNFα), a cytokine which mediates the inflammatory response. The amino acid sequence of Amgevita is identical to that of the reference product, adalimumab. The product will be available in a prefilled syringe and pre-filled pen (SureClick®autoinjector) to support dosing according to the approved dosage recommendations in each indication.
In combination with methotrexate, Amgevita is indicated for:
– Moderate-to-severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate,
– Severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate and
– Active polyarticular juvenile idiopathic arthritis in children age two years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
In monotherapy Amgevita is indicated in cases of:
– Intolerance to methotrexate or when continued treatment with methotrexate is inappropriate;
– Active polyarticular juvenile idiopathic arthritis in patients from the age of two years, who have had an inadequate response to one or more DMARDs;
– Active enthesitis-related arthritis in patients six years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy;
– Adults with severe active ankylosing spondylitis, who have had an inadequate response to conventional therapy;
– Adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant of, non-steroidal anti-inflammatory drugs;
– Active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate;
(Amgevita reduces the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and improves physical function);
– Moderate-to-severe chronic plaque psoriasis in adult patients, who are candidates for systemic therapy;
– Severe chronic plaque psoriasis in children and adolescents from four years of age, who have had an inadequate response to, or are inappropriate candidates for, topical therapy and phototherapies;
– Active moderate-to-severe hidradenitis suppurativa (HS) (acne inversa) in adult patients, with an inadequate response to conventional systemic HS therapy;
– Moderate to severe active Crohn’s disease in adult patients, who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant, or who are intolerant of, or have medical contraindications for, such therapies;
– Severely active Crohn’s disease in pediatric patients from six years of age, who have had an inadequate response to conventional therapy including: primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to, or have contraindications for, such therapies;
– Moderate to severely active ulcerative colitis in adult patients, who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant of, or have medical contraindications for, such therapies and
– Non-infectious intermediate, posterior and panuveitis in adults, who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
Important Safety Information.
Amgevita treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Amgevita is indicated.
The most serious side effects that may occur during Amgevita treatment include: Infections, such as: sepsis or other opportunistic infections, tuberculosis (TB), hepatitis B reactivation (HBV) and other malignancies including: leukemia, lymphoma and hepatosplenic T-cell lymphoma (HSTCL).
Other rare serious haematological, neurological and autoimmune reactions that may occur during Amgevita treatment include: Pancytopenia, aplastic anaemia, central and peripheral demyelinating events, lupus, lupus-related conditions and Stevens-Johnson syndrome.
The most common side effects are infections in the nose and throat, sinuses and upper respiratory tract, injection site reactions (redness, itching, bleeding, pain or swelling), headache, muscle and bone pain.
People with sensitivities to the active substance, or certain excipients (e.g., glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide (for pH adjustment) and water for injections), in people with active TB or other severe infections such as: sepsis and opportunistic infections, and those with moderate to severe heart failure (NYHA class III/IV).
Patients on Amgevita may receive concurrent vaccinations, except for live vaccines.
Please refer to the Summary of Product Characteristics for full European prescribing information.
The good news for Amgen is the fact that adalimumab has already shown it is a best seller, generating billions of dollars in annual revenues. We also believe that the EC approval of AmgevitaTM is great news for European patients who need such a drug and will be able to get it as a biosmilar from Amgen. Amgen is a superior accurate and meticular drug maker and developer. The news is great for the healthcare budget of the European governments and for the other third party payers as well.
This approval marks Amgen’s 10th product to be approved from its biosimilar pipeline.