"The launch of AMGEVITA in
"Building on our strong inflammatory disease presence in
About AMGEVITATM (biosimilar adalimumab) in
AMGEVITA is a biosimilar to adalimumab, 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. AMGEVITA 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.
AMGEVITA, in combination with methotrexate, is indicated for:
AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. AMGEVITA reduces the rate of progression of joint damage as measured by X-ray and improves physical function, when given in combination with methotrexate.
AMGEVITA, in combination with methotrexate, is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of two years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has not been studied in patients aged less than two years.
AMGEVITA is indicated for the treatment of 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.
AMGEVITA is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
AMGEVITA is indicated for the treatment of 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.
AMGEVITA is indicated for the treatment of 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.
AMGEVITA is indicated for the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
AMGEVITA is indicated for the treatment of 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.
AMGEVITA is indicated for the treatment of active moderate-to-severe hidradenitis suppurativa (HS) (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy.
AMGEVITA is indicated for the treatment of moderately to severely 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.
AMGEVITA is indicated for the treatment of moderately to 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.
AMGEVITA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant of or have medical contraindications for such therapies.
AMGEVITA is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
AMGEVITATM EU Important Safety Information
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
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 and muscle and bone pain.
AMGEVITA is contraindicated in 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 tuberculosis 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.
About Amgen Biosimilars
Amgen Biosimilars is committed to building upon
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of
No forward-looking statement can be guaranteed, and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in
View original content to download multimedia:http://www.prnewswire.com/news-releases/amgen-launches-amgevita-biosimilar-adalimumab-in-markets-across-europe-300731419.html