FDA Outlines New Plans for Biosimilars in 4 Guidance Documents and Proposed Rule
December 12th 2018On Tuesday, the FDA took significant steps toward a long-awaited transition of insulins and other products that have historically been regulated as drugs and follow-ons to regulation as biologics and biosimilars.
More than 300 Stakeholder Groups Call on Congress to Block Proposed IPI Model
December 11th 2018Yesterday, 339 patient, provider, and caregiver groups, on behalf of the Part B Access for Seniors and Physicians Coalition, sent a letter to Congress encouraging lawmakers to block the implementation of the International Pricing Index (IPI) model that was announced last month.
United States Still Lags Behind Other Nations in Adopting Biosimilar Filgrastim
December 11th 2018Since the advent of biosimilar filgrastim, patient access to the prophylaxis of chemotherapy-induced febrile neutropenia has improved in many regulatory territories, yet concerns remain about whether the United States is keeping pace with the rest of the world in biosimilar uptake and associated patient access.
Novartis Prepares to Defend Omalizumab Market as Potential Biosimilars Advance
December 10th 2018In October, the FDA granted approval for a pre-filled syringe formulation of the reference product. Additionally, Novartis is looking to expand omalizumab’s indications, as it recently earned FDA’s breakthrough therapy designation in August 2018 as a treatment for food allergies.
European Drug Makers Told to Brace for 6 Months of Trade Delays on Pharmaceuticals
December 10th 2018With the likelihood increasing that the United Kingdom will leave the European Union without a trade agreement in early 2019, the UK Health Secretary, Matt Hancock, has issued new advice to the pharmaceutical industry in which he warned that there could be long border delays that seriously impact the flow of pharmaceuticals in Europe.
SB3 Shows Comparable Efficacy and Safety to Reference Trastuzumab at 1 Year
December 10th 2018Samsung Bioepis has announced that a 1-year follow-up study comparing event-free survival in patients treated with SB3, a biosimilar trastuzumab (approved in Europe as Ontruzant) showed that the biosimilar has similar safety and efficacy profiles to the reference Herceptin.
Ahead of Udenyca Launch, Coherus Signs 340B Contract Agreement With Apexus
December 9th 2018Coherus Biosciences, which recently gained its first biosimilar approval for Udenyca, a pegfilgrastim biosimilar referencing Neulasta, has announced that it has signed a 340B prime vendor program contract with Apexus LLC.
Genentech's Civil Suit Against JHL Alleges Proof of Criminal Theft of Trade Secrets
December 8th 2018The complaint includes a screenshot of Xanthe Lam’s Genentech-issued computer, which shows a folder titled “JHL” that contained subfolders, 4 of which were named for Genentech medicines for which JHL was in the process of developing a biosimilar.
The FDA Biosimilar Action Plan: Making Biologics More Accessible
December 7th 2018While other stakeholders also need clarification of the FDA policies, it is the developers who will make it possible to bring lower-cost biosimilars to make a real difference. In this paper, I am providing comments on the proposed action plans of the FDA and pointing out what I believe to be the missing elements.
FTC "Ready to Work Closely" With FDA on Abuse of Citizen Petitions
December 6th 2018In revised draft guidance published in October 2018, the FDA announced its intention to crack down on citizen petitions that seek to delay competition from generic or biosimilar drugs. Now, in a comment letter, the Federal Trade Commission (FTC) has said that it stands ready to work with the FDA on curtailing abusive petitions.
CVS Launches New Plan That Will Pass Drug Rebates Back to Health Plans
December 6th 2018After increased pressure on pharmacy benefit managers to remake their approaches to rebates, CVS Health has announced that it will offer a new prescription benefit option in 2019 that will pass all drug makers' rebates back to its plan clients.
New Treatment Guideline for PsA Recommends First-Line Anti-TNF Biologics
December 5th 2018This week, the American College of Rheumatology and the National Psoriasis Foundation released a new treatment guideline for psoriatic arthritis (PsA) that contains evidence-based recommendations on caring for patients with this inflammatory disease.
EMA to Review Celltrion's Subcutaneous Infliximab Biosimilar
December 4th 2018Celltrion has announced that the European Medicines Agency (EMA) has accepted for review an extension marketing authorization application for a subcutaneous formulation of the company’s biosimilar infliximab, CT-P13 (sold in Europe as Remsima and in the United States as Inflectra).
Boehringer Ingelheim to Pull Out of EU Biosimilars Market, Focus on US
November 29th 2018Earlier this week, Bioprocess International reported that Boehringer Ingelheim (BI) had decided to focus on launching its biosimilar products solely in the US market, and would forego launches in the European Union. The Center for Biosimilars® was able to independently confirm this report in an email with a representative from BI.
JCR Launches the First Biosimilar Agalsidase Beta
November 29th 2018JCR Pharmaceuticals announced yesterday that it has launched its biosimilar agalsidase beta product, referencing Fabrazyme, in Japan for the treatment of Fabry disease. JCR developed the drug in partnership with Amicus Therapeutics and GlaxoSmithKline.