Biosimilar
USFDA approves Amjevita, a biosimilar to Humira
The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.
Amjevita is approved for the following indications in adult patients:
- moderately to severely active rheumatoid arthritis;
- active psoriatic arthritis;
- active ankylosing spondylitis (an arthritis that affects the spine);
- moderately to severely active Crohn’s disease;
- moderately to severely active ulcerative colitis; and
- moderate to severe plaque psoriasis.
Amjevita is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older.
Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.
“This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
Biological products are generally derived from a living organism and can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.
The FDA’s approval of Amjevita is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Amjevita is biosimilar to Humira. It has been approved as a biosimilar, not as an interchangeable product.
The most serious known side effects with Amjevita are infections and malignancies. The most common expected adverse reactions with Amjevita are infections and injection site reactions.
Like Humira, the labeling for Amjevita contains a Boxed Warning to alert health care professionals and patients about an increased risk of serious infections leading to hospitalization or death. The Boxed Warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including adalimumab products. The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.
Amjevita is manufactured by Amgen, Inc., of Thousand Oaks, California. Humira was approved in December 2002 and is manufactured by AbbVie Inc. of North Chicago, Illinois.
Source: 1
USFDA approved BIOSIMILAR Drug for Inflammation
The U.S. Food and Drug Administration approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998.
Erelzi is administered by injection for the treatment of:
- moderate to severe rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate (MTX);
- moderate to severe polyarticular juvenile idiopathic arthritis in patients ages two and older;
- active psoriatic arthritis, including use in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone;
- active ankylosing spondylitis (an arthritis that affects the spine); and
- chronic moderate to severe plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy.
Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.
“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product.”
Biological products are generally derived from a living organism and can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety and effectiveness from the reference product, in addition to meeting other criteria specified by law.
The FDA’s approval of Erelzi is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Erelzi is biosimilar to Enbrel. Erelzi has been approved as a biosimilar, not as an interchangeable product.
Erelzi should not be administered to patients with sepsis.
The most serious known side effects with Erelzi are infections, neurologic events, congestive heart failure and hematologic events. The most common expected adverse reactions with Erelzi are infections and injection site reactions.
Erelzi contains a Boxed Warning to alert health care professionals and patients about an increased risk of serious infections leading to hospitalization or death, including tuberculosis, invasive fungal infections (such as histoplasmosis) and others. The Boxed Warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including etanercept products. The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.
Erelzi is manufactured by Sandoz Inc., based in Princeton, New Jersey, at Novartis Pharma in Stein, Switzerland. Enbrel is manufactured by Amgen Inc., of Thousand Oaks, California.
Phase I approval for Humira biosimilar
Oncobiologics, Inc. has received approval to initiate a phase I clinical trial in Europe for its first biosimilar molecule, ONS-3010, a highly biosimilar version of the marketed drug, Humira.
After reviewing Oncobiologics’ Clinical Trial Application, the Centrale Commissie Mensgebonden Onderzoek (CCMO), the Dutch Competent Authority, has provided a Letter of No Objection, and the Independent Ethics Committee of the Foundation “Evaluation of Ethics in Biomedical Research” has approved a Phase I trial to be conducted by the Center for Human Disease Researchin Leiden, The Netherlands. The study is expected to be completed before the end of 2014.
“After a very successful development campaign, we are excited to see our first biosimilar molecule enter thisPhase I study. This represents the culmination of two years of hard work by our team, as well as proof-of-concept for our biosimilars business model, BioSymphony, which integrates our world-class CMC and manufacturing capabilities with the external clinical expertise of inVentiv Health, a top global CRO, and several regionally strong commercial partners around the world,” commented Oncobiologics founder & chief executive officer, Pankaj Mohan.
Aldeyra chief executive officer, Todd C. Brady added, “As an advisor, I have witnessed the rapid development of Oncobiologics and am thrilled to see the company take this exciting step. Oncobiologics has built a team of respected industry leaders within the framework of an agile startup. It is a testament to that team that Oncobiologics has been able to satisfy the challenging regulatory hurdles surrounding the development of complex mAb biosimilars. I look forward to the successful completion of this trial as well as the continued advancement of other potential products in the Oncobiologics pipeline.”
Oncobiologics is developing several additional biosimilars, including a biosimilar version of Avastin, which will be filed for its first clinical trial later in 2014. Oncobiologics is also pursuing biosimilar versions of Herceptin, Rituxan and Erbitux with plans to initiate studies in 2015 and thereafter.
Oncobiologics is a privately-held biopharmaceutical company developing a pipeline of biosimilars and next generation biotherapeutics. Formed by a team of leading industry experts from firms such as Eli Lilly, Bristol-Myers Squibb, Amgen, Genentech, Merck and Pfizer, Oncobiologics operates from a state-of-the-art 35,000 sq. ft. fully integrated R&D and Manufacturing facility in Cranbury, NJ.
The BioSymphony™ biosimilars business model is designed to ensure that biosimilar assets meet the stringent requirements of U.S. and European regulators, while also achieving accelerated development and technical excellence in creating affordable medicines for patients who so urgently need them. The model leverages Oncobiologics’ in-house CMC, biomanufacturing expertise and infrastructure with subject matter expert partners from around the globe to create a world-class biosimilars commercialisation engine. The Oncobiologics R&D function features cell line development, analytical and formulation development, and upstream and downstream process development. The R&D facility is outfitted with a state-of-the-art cGMP single-use manufacturing platform for producing clinical material and is being expanded to handle commercial launch with twin 2000-liter single-use bioreactor lines. Oncobiologics’ CMC and Regulatory functions are closely integrated with partner inVentiv Health, a global leader in clinical development. The BioSymphony model is on target to generate three monoclonal antibody products per year from 2017-2018.
Source: PharmaBiz
Campaign for Affordable Trastuzumab demands review of biosimilar guidelines
The Campaign for Affordable Trastuzumab, a platform working in the health sector to make trastuzumab affordable, has demanded to the union health ministry an urgent re-appraisal of the biosimilar guidelines in the wake of the Delhi High Court order dated February 5, 2014 in which the court has granted stay on the marketing of a biosimilar of the breast cancer drug trastuzumab.
“The Campaign for Affordable Trastuzumab demands an urgent re-appraisal of the biosimilar guidelines. The guidelines must be geared to encouraging innovation, fostering competition and lowering prices, rather than to enable originators to protect their monopolies and reap unethical profits,” said Kalyani Menon-Sen, coordinator of the Campaign, which was launched in November 2012 and endorsed by over 200 Indian and global patient associations, cancer survivors, health movements, women’s rights activists and eminent jurists. The Campaign has since been demanding that the government of India intervene to enable the production of biosimilars and ensure that the drug is made available to all those who can benefit from it.
Deploring the ex parte order of the Delhi High Court on a petition by Swiss pharma major Roche, granting stay on the marketing of a biosimilar of the breast cancer drug trastuzumab, the Campaign said that it seems that the order has been issued with little concern for the Supreme Court guideline on ex-parte injunctions. Since getting such injunctions vacated or cleared is a time-consuming and complicated process, the SC has laid down that interim injunctions or stay orders should be granted only after hearing the defendants/respondents.
Even in exceptional cases where ex-parte injunctions are granted, the SC guidelines direct the court to record in the order that if the suit is eventually dismissed, the plaintiff or the petitioner will have to pay full restitution, actual or realistic costs and profits. Both these directions have been ignored in the present order, it said.
The action of the court in giving an interim ex-parte injunction in a case where access to a life-saving drug is at stake, is unwarranted and inexplicable.
Significantly, Roche was a member of the drafting committee for the biosimilar guidelines, which have been invoked in this plea. This move by Roche bears out our contention that the guidelines are weighted against innovators in developing countries, and are likely to be used by big pharma to protect its own interests, the Campaign said.
Source: PharmaBiz
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