Can Modeling and Simulation Drive Clinical Development of Biosimilars?
December 5th 2017The failure rate of biosimilars in clinical trials is considered high because of the complex manufacturing process and the high variability expected for biologics. With associated development costs for a biosimilar estimated to be $100 million, there is a high risk-cost relationship in the establishing clinical biosimilarity.
CVS Health Agrees to Buy Aetna, Possibly Reshaping US Healthcare
December 4th 2017CVS Health has agreed to purchase Aetna, a transaction that would combine CVS’s retail pharmacies with Aetna’s health insurance company in a $69 billion deal that could create a company with annual revenue of $240 billion, and that has the potential to reshape the US healthcare system.
Biocad to Manufacture Biosimilars in Morocco
December 2nd 2017Russian biosimilar developer Biocad has announced that it will begin manufacturing its rituximab and bevacizumab biosimilars in Morocco. The 2 drugs, manufactured in partnership with Sothema Labs, will be sold in numerous markets in North Africa, including Morocco, Senegal, Gabon, and Cote d’Ivoire.
COA Holds Emergency Hill Day to Warn Congress on Medicare Sequester
December 2nd 2017Yesterday, community oncology leaders flooded the Hill to meet with Congress and the administration to warn them of the impact the Medicare sequester’s increased cuts and extension will have on cancer care nationwide.
Systematic Review Identifies 6 Trends in US Biosimilar Approvals
November 30th 2017Because biosimilars are relatively new to the United States, drug makers pursuing FDA approval for biosimilars seek additional information about the kinds and quantities of evidence that the agency uses to approve these therapies.
SCOTUS Hears Case That Could End IPRs for Biosimilar Developers
November 29th 2017This week, the Supreme Court of the United States heard oral arguments in Oil States Energy Services, LLC v Greene’s Energy Group, LLC, a case that asks the court to decide whether inter partes review (IPR) is constitutional.
Researchers Find Low Infection Risk With Denosumab Plus Other Biologics
November 29th 2017A recent study was conducted to determine whether the concurrent use of denosumab with a biologic disease-modifying antirheumatic drug (bDMARD), such as adalimuab, etanercept, or infliximab, increases the risk of infection.
Study Finds High Rates of Switching, Discontinuation of Biologics Among Patients With AS
November 28th 2017Patients with ankylosing spondylitis (AS) may benefit from biologic therapies, including anti–tumor necrosis factor (anti-TNF) treatments including adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi), and infliximab (Remicade or its biosimiars, Inflectra and Renflexis).
Biologics, and Costs, Are on the Rise in IBD Treatment, Study Finds
November 28th 2017Biologics are increasingly used in the treatment of inflammatory bowel disease (IBD), but real-world data quantifying the costs of these therapies have been lacking. A new study, published in Alimentary Pharmacology and Therapeutics, sought to determine trends in costs and relative market share of IBD therapies in the United States over the past 9 years.
Humira Competitor Tremfya Gains European Approval for Psoriasis Treatment
November 28th 2017Janssen-Cilag International’s biologic drug guselkumab (Tremfya) has received approval from the European Commission (EC) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Will Biosimilar Trastuzumab Change Clinical Practice?
November 27th 2017Trastuzumab has been used to manage both early and metastatic HER2-postive breast cancer and has significantly improved the survival of these patients and become the standard of care, according to Arlene Chan, MB BS, FRACP, MMed, writing in Chinese Clinical Oncology.
CMS Proposes Policy to Lower the Cost of Biosimilars
November 27th 2017CMS is proposing a change to lower cost-sharing and improve enrollee incentives to choose biosimilars over reference biologics, and to reduce costs to both Medicare Part D enrollees and the Part D program. This objective would be accomplished by revising the definition of generic drug (§ 423.4) to include follow-on biologic products approved under the section 351(k) biosimilar pathway.
Review of Systemic Treatment of Psoriasis Recommends Biologics
November 25th 2017A new review discusses the systemic treatment of psoriasis and recommends biologics and biosimilars for long-term treatment of psoriasis because of their better tolerability and safety compared with other systemic treatments, which are limited largely by poor tolerability and cumulative toxicity.
Genentech Releases New Data on Reference Bevacizumab and Atezolizumab Plus Chemotherapy
November 25th 2017A new study, the phase 3 IMpower150, demonstrated Genentech’s atezolizumab (Tecentriq) and innovator bevacizumab (Avastin) plus paclitaxel and carboplatin chemotherapy significantly reduced the risk of disease worsening or death in the treatment of advanced lung cancer.
Survey: Canadian Physicians Support Distinguishable Names for Biologics, Biosimilars
November 23rd 2017Results of a new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) shows that Canadian physicians support the use of distinguishable names for biologic therapies, including biosimilars,