The Promise of Biosimilars

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What is the role of biosimilars in the biologics market? How do they effect patients, providers…etc? What is their impact on innovation? As discussed in our previous post “Biosimilars Approval: Opportunities and Challenges,” Biosimilars are drug products that are “highly similar” to an FDA-approved biological product. As the contemporary cousin of the generic drug, biosimilars
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Demand for Experts When the Stakes are High – The Added Value of KOLs

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A Key Opinion Leader (KOL) is an individual who has achieved such a significant social or professional status in a certain community, such as doctors, researchers, lawyers, celebrities, etc., that their recommendations can impact the decision-making process of their peers. The benefits of engaging KOLs is apparent in almost every industry but has been particularly
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FDA Advisory Committee Gives Amgen Green Light on New Indication for Blincyto®

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On March 7th, 2018 the Oncologic Drugs Advisory Committee (ODAC) gathered to discuss supplemental biologic license application (sBLA) 125557/S-013, for Blincyto ® (blinatumomab) injection for intravenous use via Amgen, Inc.  The panel discussed the proposed indication for the treatment of minimal residue disease-positive B-cell precursor acute lymphoblastic leukemia (MRD+ ALL).  Amgen’s blinatumomab was awarded breakthrough therapy
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FDA Panel Denies Aradigm the Opportunity to Market Inhaled Antibiotic Treatment for Non-Cystic Fibrosis Bronchiectasis Patients

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The Antimicrobial Drugs Advisory Committee (AMDAC) convened on January 11th, 2018 to discuss new drug application 210693, ciprofloxacin dispersion for inhalation (LINHALIQ), sponsored by Aradigm Corp. The panel discussed the proposed indication of treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infection with Pseudomonas aeruginosa. Aradigm has since received a complete response letter
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FDA Panel Denies Clarus and Lipocine a Run at the First Oral Testosterone Replacement Therapy

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The Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) met on January 9th and 10th to discuss two potential oral testosterone formulations: Jatenzo (Clarus Therapeutics) and Tlando (Lipocine). Both formulations are the first proposed oral testosterone replacement therapy for males with conditions associated with a deficiency or absence of testosterone, such as congenital/acquired primary hypogonadism
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FDA Panel Conducts Safety Review of Gadolinium Retention in the Brain from Gadolinium Based Contrast Agents

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On September 8th, the Medical Imaging Drugs Advisory Committee (MIDAC) discussed the potential risk of systemic gadolinium retention, especially in the brain, in patients receiving gadolinium-based contrast agents (GBCAs) used for magnetic resonance imaging (MRI) diagnostic procedures. This was a multi-sponsor meeting, which included Bayer Healthcare, Bracco Diagnostics, GE Healthcare, and Guerbet. The meeting began
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Mylan Achieves Unanimous Support for MYL-1401O: A Proposed Biosimilar to Genentech’s Herceptin (trastuzumab)

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The FDA’s Oncologic Drugs Advisory Committee (ODAC) met on the afternoon of July 13th to discuss Biologics License Application (BLA) 761074 for Mylan’s biosimilar to Genentech Inc.’s Herceptin (trastuzumab), MYL-1401O. MYL-1401O’s proposed indications include: Adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer; in
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Amgen Gains Unanimous Approval for ABP 215: A Proposed Biosimilar to Genentech/Roche’s AVASTIN (bevacizumab)

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The FDA’s Oncologic Drugs Advisory Committee (ODAC) met on the morning of July 13th to discuss Biologics License Application (BLA) 761028 for Amgen’s biosimilar to Genentech/Roche’s AVASTIN (bevacizumab), ABP 215. ABP 215’s proposed indications include: non-squamous non-small cell lung cancer, metastatic colorectal cancer, metastatic renal cell carcinoma, glioblastoma, and cervical cancer. ABP 215 is a
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FDA Approves Kymriah, the First Ever Therapy Based on Gene Transfer

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On July 12th, 2017 the FDA’s Oncologic Drugs Advisory Committee (ODAC) discussed biologics license application (BLA) 125646 for tisagenlecleucel-T suspension (KYMRIAH™), developed by Novartis. The proposed indication for KYMRIAH™ is the treatment of pediatric and young adult patients, ranging in age from 3-25 years, with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). KYMRIAH™ works by obtaining
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WYETH GAINS FDA COMMITTEE SUPPORT FOR INTRAVENOUS GEMTUZUMAB: A TREATMENT FOR ADULTS WITH DE NOVO ACUTE MYELOID LEUKEMIA

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On July 11th the Oncologic Drugs Advisory Committee (ODAC) held a half-day meeting to discuss the biologics license application (BLA) 761060 for MYLOTARG (gemtuzumab ozogamicin). Gemtuzumab is a monoclonal antibody (MAB), which is indicated for use in combination therapy with daunorubicin (DNR) and cytarabine (AraC), for the treatment of adults with previously untreated de novo
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