First Regulatory Approval for Company’s Biosimilar Portfolio
First Biosimilar Adalimumab Approved by FDA
THOUSAND OAKS, CA, USA I September 23, 2016 I Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved AMJEVITA™ (adalimumab-atto) across all eligible indications of the reference product, Humira® (adalimumab). AMJEVITA is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis. AMJEVITA is Amgen’s first biosimilar to receive regulatory approval.
“Approval of AMJEVITA is an exciting accomplishment as it marks a new chapter in Amgen’s story of being a leader in biotechnology. In addition, AMJEVITA holds the potential to offer patients with chronic inflammatory diseases an additional treatment option,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “This milestone exemplifies our ongoing dedication to the development of high quality biologic medicines.”
The approval of AMJEVITA was based on a comprehensive data package supporting biosimilarity to adalimumab based on analytical, nonclinical, 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 clinical equivalence to adalimumab. Safety and immunogenicity of AMJEVITA were also comparable to adalimumab.
The Company’s biosimilar adalimumab is also undergoing review by the European Medicines Agency, following a regulatory application submitted in December 2015. Biosimilar adalimumab is one of nine programs included in Amgen’s robust pipeline of biosimilars.
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 is 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™ U.S. Important Safety Information
SERIOUS INFECTIONS
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:
- Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before AMJEVITA™ use and during therapy. Initiate treatment for latent TB prior to AMJEVITA™ use.
- Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
- Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.
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.
- Do not start AMJEVITA™ during an active infection, including localized infections.
- Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
- If an infection develops, monitor carefully and initiate appropriate therapy.
- Drug interactions with biologic products: A higher rate of serious infections has been observed in rheumatoid arthritis patients treated with rituximab who received subsequent treatment with a TNF blocker. Concurrent use of AMJEVITA™ with biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.
MALIGNANCY
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.
- Consider the risks and benefits of TNF-blocker treatment prior to initiating or continuing therapy in a patient with known malignancy.
- In clinical trials of some TNF-blockers, including adalimumab products, more cases of malignancies were observed among TNF-blocker-treated patients compared to control patients.
- Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with AMJEVITA™.
- In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
- Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.
HYPERSENSITIVITY
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.
NEUROLOGIC REACTIONS
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.
HEMATOLOGICAL REACTIONS
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 or new onset congestive heart failure (CHF) may occur; exercise caution and monitor carefully.
AUTOIMMUNITY
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.
IMMUNIZATIONS
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. 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.
ADVERSE REACTIONS
The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.
Please see full Prescribing Information, including Medication Guide.
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.
For more information, visit www.amgenbiosimilars.com and follow us on www.twitter.com/amgenbiosim.
About Amgen
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.
SOURCE: Amgen
Post Views: 52
First Regulatory Approval for Company’s Biosimilar Portfolio
First Biosimilar Adalimumab Approved by FDA
THOUSAND OAKS, CA, USA I September 23, 2016 I Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved AMJEVITA™ (adalimumab-atto) across all eligible indications of the reference product, Humira® (adalimumab). AMJEVITA is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis. AMJEVITA is Amgen’s first biosimilar to receive regulatory approval.
“Approval of AMJEVITA is an exciting accomplishment as it marks a new chapter in Amgen’s story of being a leader in biotechnology. In addition, AMJEVITA holds the potential to offer patients with chronic inflammatory diseases an additional treatment option,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “This milestone exemplifies our ongoing dedication to the development of high quality biologic medicines.”
The approval of AMJEVITA was based on a comprehensive data package supporting biosimilarity to adalimumab based on analytical, nonclinical, 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 clinical equivalence to adalimumab. Safety and immunogenicity of AMJEVITA were also comparable to adalimumab.
The Company’s biosimilar adalimumab is also undergoing review by the European Medicines Agency, following a regulatory application submitted in December 2015. Biosimilar adalimumab is one of nine programs included in Amgen’s robust pipeline of biosimilars.
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 is 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™ U.S. Important Safety Information
SERIOUS INFECTIONS
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:
- Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before AMJEVITA™ use and during therapy. Initiate treatment for latent TB prior to AMJEVITA™ use.
- Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
- Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.
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.
- Do not start AMJEVITA™ during an active infection, including localized infections.
- Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
- If an infection develops, monitor carefully and initiate appropriate therapy.
- Drug interactions with biologic products: A higher rate of serious infections has been observed in rheumatoid arthritis patients treated with rituximab who received subsequent treatment with a TNF blocker. Concurrent use of AMJEVITA™ with biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.
MALIGNANCY
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.
- Consider the risks and benefits of TNF-blocker treatment prior to initiating or continuing therapy in a patient with known malignancy.
- In clinical trials of some TNF-blockers, including adalimumab products, more cases of malignancies were observed among TNF-blocker-treated patients compared to control patients.
- Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with AMJEVITA™.
- In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
- Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.
HYPERSENSITIVITY
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.
NEUROLOGIC REACTIONS
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.
HEMATOLOGICAL REACTIONS
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 or new onset congestive heart failure (CHF) may occur; exercise caution and monitor carefully.
AUTOIMMUNITY
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.
IMMUNIZATIONS
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. 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.
ADVERSE REACTIONS
The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.
Please see full Prescribing Information, including Medication Guide.
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.
For more information, visit www.amgenbiosimilars.com and follow us on www.twitter.com/amgenbiosim.
About Amgen
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.
SOURCE: Amgen
Post Views: 52
