Senate Bill Seeks to Give FTC Authority to Fight Patent Thickets, Product Hopping
May 15th 2019The bill codifies definitions of product hopping and patent thicketing within the Federal Trade Commission (FTC) statute, allowing the FTC to challenge these practices as anticompetitive and to enable the FTC to bring antitrust suits against drug companies.
FDA Hears From Stakeholders About Insulin Transition to Biologic Pathway in 2020
May 14th 2019Set against a backdrop of rising concern about the cost of insulin, the FDA held a hearing about biosimilar insulins Monday, 10 months before the products transition in March 2020 from the Food Drug and Cosmetic Act to biologics under the Public Health Service Act.
HTA Frameworks for RA Therapies Need Improvement, Researchers Say
May 13th 2019Cost-effectiveness models for the treatment of rheumatoid arthritis (RA) first emerged in the early 2000s when highly effective but also high-cost biologic therapies began to reach patients. However, these health technology assessment (HTA) models need improvement, a recent paper says.
FDA Guidance on Biosimilar Interchangeability Hits the Right Points, Stakeholders Say
May 13th 2019The guidance explains that the data and information needed to meet the legal standard for interchangeability, which shows that the proposed interchangeable product can be expected to produce the same clinical result as the reference product in any given patient, will vary by case.
Australia's GBMA Launches Hub for Biosimilar Education
May 13th 2019In 2018, The Generic Biosimilar Medicines Association (GBMA) was awarded the Biosimilar Education Grant by the Australian government to develop an educational program for Australian stakeholders with the aim of increasing confidence in biosimilars that are listed on the nation’s public drug benefit plan. Now, the GBMA has launched an educational hub.
Biosimilars Promise a Brighter Future for Latin American Patients
May 13th 2019Discussion related to these products has changed dramatically from those had in previous years; in the past, the industry was discussing the regulatory framework and how the different regulatory agencies, from Mexico to Argentina, would regulate these new therapeutic options. Now, after the maturity of the laws and the construction of different regulatory pathways for biosimilars in most of the countries, the discussion has moved on to the different challenges that the industry, whether local or foreign, faces in commercializing biosimilars.
Study Finds Fewer Severe Infections With Newer Psoriasis Therapies Versus Methotrexate
May 10th 2019Patients with psoriasis taking new prescriptions of apremilast, etanercept, and ustekinumab had a decreased rate of serious infection compared with those taking methotrexate, according to an analysis of medical records from 2 large US claims databases.
CBO Says Bill to Curb Pay-for-Delay Would Cut the Deficit by $613 Million Over 10 Years
May 10th 2019The bill seeks to prohibit brand-name drug makers from delaying the entry of generics or biosimilars by compensating competitors to keep their products off the market for a period of time in so-called pay-for-delay arrangements.
Eculizumab Shows Positives Results in Cutting Relapses of Neuromyelitis Optica Spectrum Disorder
May 9th 2019A phase 3 trial of eculizumab found the drug reduced the frequency of relapse neuromyelitis optica spectrum disorder (NMOSD), an autoimmune, inflammatory disorder that typically affects the optic nerves and spinal cord.
Innovent and Eli Lilly's Rituximab Biosimilar Meets Primary End Points in PK and Phase 3 Studies
May 9th 2019China-based biosimilar developer Innovent and Eli Lilly and Company announced this week that 2 studies of IBI301, a proposed rituximab biosimilar being jointly developed by the 2 drug makers, met their primary end points.
HHS Sets Details of Finalized Rule Requiring List Prices to Be Disclosed in DTC Ads
May 8th 2019In an effort to improve price transparency, the Trump administration on Wednesday announced a final rule requiring drug manufacturers to disclose their list prices for pharmaceutical products or biologics in television ads for drugs covered by Medicare or Medicaid if the wholesale acquisition cost is $35 or more for a month’s supply. Affected drugs include adalimumab (Humira), with its wholesale acquisition cost (WAC) of $5174 per month, and etanercept (Enbrel), with its WAC of $5174 per month.
In Comment Letters, Stakeholders Call on FDA to Change Course on Biosimilar Naming
May 8th 2019This March, the FDA released updated guidance on the naming of biologics, biosimilars, and interchangeable biosimilars. In the document, the FDA indicated that it no longer intends to retroactively give approved biologics 4-letter suffixes devoid of meaning, but it will continue to assign suffixes to newly approved innovator biologics, biosimilars, or interchangeable biosimilars. In addition, FDA does not intend to add suffixes to the names of transition products. This week, the comment period on the updated guidance closed, and the FDA heard from a variety of stakeholders who asked the agency to change its direction.
Specter of FTC Involvement Raised at Senate Hearing About Intellectual Property
May 8th 2019The idea of giving the Federal Trade Commission (FTC) more authority to cut through patent thickets blocking biosimilar competition was raised Tuesday during a hearing of the Senate Judiciary Committee about intellectual property, patent law, and the impact on drug prices.
Roche Gets a Boost from New Kadcyla Indication as US Biosimilars of Herceptin Near
May 7th 2019Yesterday, the FDA approved Roche’s ado-trastuzumab emtansine (Kadcyla) for the adjuvant treatment of HER2-positive early breast cancer in patients who have residual invasive disease after neoadjuvant taxane- and trastuzumab-based therapy. The new indication could help to stave off some of the impact of biosimilar trastuzumab, which is expected to launch this year.
As Evidence Base for Biosimilars Grows, So Too Will Confidence in Switching, Review Says
May 7th 2019Despite potential benefits of biosimilar adoption in terms of both patient access and healthcare system sustainability, and despite ongoing efforts at patient and provider education on biosimilars, stakeholders may continue to have concerns about perceived risks with switching. A new review of the available literature on switching—from randomized controlled trials and real-world evidence—sought to address those concerns, and said that additional education and ongoing real-world evidence collection will be necessary to increasing stakeholder comfort with these agents.
Eye on Pharma: Fresenius Kabi Launches Biosimilar Adalimumab, Idacio
May 6th 2019Fresenius Kabi, maker of the EU-authorized biosimilar adalimumab, Idacio, has launched its product in Germany. Fresenius Kabi has made the biosimilar available for sale in pre-filled syringe, pre-filled pen, and vial presentations.
Amgen Settles With One Biosimilar Developer, Sues Another
May 6th 2019Last week, biosimilar developer Coherus BioSciences announced that it has reached a settlement with innovator drug maker Amgen over a trade secret case that was pending in the Superior Court of California. Separately, Amgen filed a new complaint against biosimilar developer Samsung Bioepis.
A Look Behind the US Debate Over Insulin Prices
May 6th 2019One main reason for increasing insulin prices is rebates. During the April 10, 2019 United States House Energy and Commerce Committee hearing titled “Priced Out of a Lifesaving Drug: getting Answers on the Rising Cost of Insulin” manufacturers, pharmacy benefit managers (PBMs), and congressional representatives discussed the effects rebates were having on prices. Currently, manufacturers pay rebates to health plans or PBMs in exchange for formulary access, which is a major reason we see manufacturer net pricing declining but list prices increasing.
UK Researchers Hope Adalimumab Will Prove to be Cost Effective in Dupuytren Disease
May 4th 2019Dupuytren disease (DD), a common, fibroproliferative condition of the hand that can cause contracture of the fingers, currently has no approved treatment for its early stages, and surgical intervention is often required as the disease progresses.
CBO Single-Payer Report: Highlights of Drug Pricing, Cost Containment Ideas, Implications
May 3rd 2019The Congressional Budget Office this week released a report that examines the different components of what putting together a single-payer system could involve, as well as the implications. Here we highlight 2 sections of the report that are likely of interest to those following biosimilars, drug pricing and healthcare cost containment.
Biosimilar Infliximab, Zessly, Maintains Safety and Efficacy Under Extended In-Use Conditions
May 3rd 2019The authors concluded that the physiochemical and biological analyses demonstrated that the biosimilar is not affected by reconstitution, dilution, and extended storage in infusion bags. These findings, they write, provide added reassurance to healthcare providers that the biosimilar is safe and effective under extended in-use conditions.