First Adalimumab Biosimilar Candidate Recommended for EMA Approval
THOUSAND OAKS, Calif., Jan. 27, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of ABP 501 (biosimilar adalimumab), recommending approval for all available indications. ABP 501 has been recommended for approval for the treatment of certain inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis, psoriatic arthritis, severe 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. The CHMP opinion also recommends approval for the treatment of certain pediatric inflammatory diseases, including 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).
"The positive CHMP opinion for ABP 501 marks the first time an adalimumab biosimilar has been recommended for approval in the EU," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "This represents another significant milestone for our biosimilars portfolio and is an important step in our effort to develop high-quality biologic medicines for patients suffering from chronic inflammatory diseases."
The Marketing Authorization Application (MAA) submission for ABP 501 was based on a comprehensive data package supporting biosimilarity to adalimumab based on analytical, pharmacokinetic and clinical data, including results from two Phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. The Phase 3 studies each met their primary endpoint showing no clinically meaningful differences to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab. Data to support the transition of adalimumab patients to ABP 501 were also included in the submission.
The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, a centralized marketing authorization will be granted that will be valid in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC.
ABP 501 was approved in the United States (U.S.) by the U.S. Food and Drug Administration (FDA) on Sept. 23, 2016, where it goes by the brand name AMJEVITA™ (adalimumab-atto).
About ABP 501
ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases. The active ingredient of ABP 501 is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab.
About AMJEVITA™ (adalimumab-atto) in the U.S.
AMJEVITA is a biosimilar to adalimumab, an anti-TNF-α monoclonal antibody. The active ingredient of AMJEVITA is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as, and has been determined by FDA to be highly similar to, adalimumab. AMJEVITA will be delivered in prefilled syringe and autoinjector presentations to support dosing in each of the approved indications.
AMJEVITA is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
AMJEVITA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older.
AMJEVITA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
AMJEVITA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
AMJEVITA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy, and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
AMJEVITA is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine, or 6-mercaptopurine. The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.
AMJEVITA is indicated for the treatment of 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. AMJEVITA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
AMJEVITA is currently not available commercially. This is not an offer for sale. The following information is derived from the approved label in the U.S.
AMJEVITA™ U.S. Important Safety Information
Patients treated with AMJEVITA™ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue AMJEVITA™ if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with AMJEVITA™ prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with AMJEVITA™, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.
Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If a serious allergic reaction occurs, stop AMJEVITA™ and institute appropriate therapy.
HEPATITIS B VIRUS REACTIVATION
Use of TNF blockers, including AMJEVITA™, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in patients who are carriers of HBV and monitor them during and after AMJEVITA™ treatment. Discontinue AMJEVITA™ and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming AMJEVITA™ after HBV treatment.
TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome. Exercise caution when considering AMJEVITA™ for patients with these disorders; discontinuation of AMJEVITA™ should be considered if any of these disorders develop.
Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products. Consider stopping AMJEVITA™ if significant hematologic abnormalities occur.
CONGESTIVE HEART FAILURE
Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; exercise caution and monitor carefully.
Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.
Patients on AMJEVITA™ should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating AMJEVITA™ therapy. Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.
The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.
About Amgen Biosimilars
Amgen Biosimilars is committed to building upon Amgen's experience in the development and manufacturing of innovative human therapeutics to expand Amgen's reach to patients with serious illnesses. Biosimilars will help to maintain Amgen's commitment to connect patients with vital medicines, and Amgen is well positioned to leverage its more than 35 years of experience in biotechnology to create high quality biosimilars and reliably supply them to patients worldwide.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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