News

With patents on reference products that treat multiple sclerosis (MS) set to expire soon in the region, a panel of experts in Latin America recently published a set of recommendations regarding the efficacy, safety, and quality of biosimilars in these countries.

“Our results suggest that in patients with a contraindication to immunotherapy, such as connective tissue, rheumatologic, or interstitial lung disease, bevacizumab may be a reasonable alternative, instead of pembrolizumab, to add to carboplatin-pemetrexed,” said lead author, Stephen J. Bagley, MD, MSCE, assistant professor of hematology-oncology at Abramson Cancer Center, in a statement.

Prestige BioPharma announced this week that the European Medicines Agency (EMA) has accepted for review its Marketing Authorization Application for a proposed trastuzumab biosimilar, HD201. Prestige hopes to eventually sell the product under the name Tuznue.

In May 2019 policy news, bills touching on various aspects of biosimilars progressed through Congress, and HHS finalized 2 proposals affecting drug pricing. One state capped monthly insulin prices, while in Canada, one province will move patients taking reference biologics for rheumatological diseases and diabetes to biosimilars within 6 months.

The Center for Biosimilars® recaps the top news for the week of May 27, 2019.

The Biosimilars Forum said this week that if Congress enacted certain changes, the federal government and beneficiaries could save billions of dollars in Medicare Part B.

The Canadian Rheumatology Association (CRA) has issued an update to its position statement on biosimilars. In the document, the CRA says that evidence for the risk/benefit ratio for biosimilars is accruing rapidly, and physicians must demonstrate fiscal responsibility while providing the best care possible to individual patients.

Researchers are reporting switching data from the phase 3 EQUIRA study in patients with rheumatoid arthritis (RA), demonstrating that a single switch from the reference to the biosimilar had no impact on efficacy, safety, or immunogenicity of etanercept.

The House of Representatives has passed HR 965, the Creating and Restoring Equal Access to Equivalent Samples Act of 2019 (CREATES Act), as well as 2 other bills dealing with drug prices: HR 1499, the Protecting Consumer Access to Generic Drugs Act of 2019, and HR 938, the Bringing Low-cost Options and Competition While Keeping Incentives for New Generics (BLOCKING) Act of 2019.

Infliximab and its biosimilars are often used as a treatment for ulcerative colitis (UC), and recent years have seen the collection of real-world data on the use of biosimilar CT-P13 (Inflectra, Remsima) that confirm the product’s equivalent efficacy to that of the reference, Remicade. One newly published study, which assessed patient data from a French nationwide health administrative database, found that not only is biosimilar CT-P13 as effective as the reference product in treating UC, it may also have a lower risk of serious infections.

In its May 2019 network bulletin, UnitedHealthcare announced that, as of July 1, it will prefer the use of brand-name pegfilgrastim, Amgen’s Neulasta, over biosimilar options.

Key biopharmaceutical markets outside the United States are focusing on drug prices, and the increased use of biosimilars is a key part of their strategy, according to a report from the PwC Health Research Institute.

A new Federal Trade Commission (FTC) staff report has found that, despite an increase in patent settlements concerning generic drugs, fewer settlements included the kinds of “pay-for-delay” provisions that are likely to be anticompetitive in nature.

Officials in British Columbia announced on Monday that patients currently taking reference biologics for rheumatological diseases and diabetes will be switched to biosimilar products within 6 months.

Another piece of bipartisan legislation was introduced last week that seeks to promote biosimilars.

All children with inflammatory bowel disease (IBD) who were receiving maintenance infliximab at a single center between 2017 and 2018 were included in the study.

A study presented at the recent ISPOR 2019 meeting assessed both the cost associated with treatment with infliximab for patients at US hospitals as well as reasons for discontinuation of therapy during follow-up, and it found that insurance coverage status is one factor that plays a role in discontinuation of this therapy that rose consistently in price over the study period.

A recently released analysis from the Kaiser Family Foundation sheds new light on how rising drug prices are impacting patients' out-of-pocket spending on drugs, as well as the budgets of private and public payers.

This week, Colorado Governor Jared Polis, D, signed the nation’s first bill that will cap insulin co-pays at $100 per month for people with health insurance.

Yesterday, the Senate Committee on Health, Education, Labor, and Pensions released bipartisan draft legislation aimed at lowering the cost of healthcare in the United States.

The Center for Biosimilars® recaps the top news for the week of May 20, 2019.

Eli Lilly and Company announced this week that it has made a lower-cost insulin lispro injection available in pharmacies. The company said that the authorized version carries a list price ($137.35 per vial and $265.20 for a package of 5 pens) that is 50% lower than that of the brand-name Humalog injection.

In an analysis presented at ISPOR 2019, a team of researchers sought to demonstrate the cost to incorporate biologic treatment for patients with inflammatory diseases by using biosimilar infliximab instead of its reference.

Health Canada has approved Mylan and Biocon’s trastuzumab biosimilar, Ogivri, referencing Herceptin. The product, also approved in the United States, the European Union, and elsewhere, is the first biosimilar trastuzumab to be approved in Canada, and carries indications for HER2-positive breast cancer and HER2-positive metastatic stomach cancer.

During Digestive Disease Week 2019, held May 18-21 in San Diego, California, researchers presented the 1-year results of a phase 1 trial of subcutaneous CT-P13 versus the intravenous formulation of the biosimilar in patients with Crohn disease (CD).

The FDA today released draft guidance on the design and evaluation of comparative analytical studies that are intended to support a demonstration of biosimilarity. A previous draft guidance document on statistical approaches to evaluate analytical similarity was withdrawn in June 2018.

Extended stability data for the reference Herceptin have been published, supporting advanced preparation and dose banding. Given stability data for SB3 are limited, a new study sought to assess the extended physiochemical stability and bioactivity of the biosimilar and to evaluate the advanced preparation of the reconstituted and diluted product.

The final guidance on interchangeability resolves some issues, creates many new issues and inquiries, and offers a path—albeit not a clear one—that is filled with scientific and clinical challenges.

Patients with rheumatoid arthritis (RA) have similar rates of infection after total knee or hip replacement no matter which biologic they take, but those using glucocorticoids, even moderate doses, appear to have an increased risk of postoperative infections, according to a study published today.

Last week, CMS issued a final rule that makes changes to Medicare Advantage and Medicare Parts D and B.