This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Biosimilars have faced significant challenges in their analytical characterization. This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product.
Food and Drug Administration approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection, for the treatment of relapsing forms of multiple sclerosis, the agency announced. FRIDAY, Aug. 25, 2023 -- The U.S.
Food and Drug Administration approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection, for the treatment of relapsing forms of multiple sclerosis, the agency announced. FRIDAY, Aug. 25, 2023 -- The U.S.
The subsidiary, called Cordavis, will work directly with manufacturers to market or co-produce low-cost biologic drugs, starting with Novartis’ Humira copy.
The Biosimilar Revolution: How It's Changing the Game for Biologic Drug Manufacturers As the pharmaceutical industry continues to evolve, one trend is gaining significant attention: the rise of biosimilars. In this article, we'll explore the impact of biosimilars on biologic drug life cycle management.
Biosimilars, which are biologic drugs that are highly similar to an already approved biologic drug, are transforming the pharmaceutical industry. As patents for original biologic drugs expire, biosimilars are becoming increasingly important, offering more affordable treatment options for patients and healthcare systems.
Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with diabetes mellitus. WEDNESDAY, Feb. 19, 2025 -- The U.S. Merilog is a rapid-acting human.
The introduction of biosimilars has significantly altered the landscape of biologic drug distribution models. Biosimilars, which are highly similar to […] Source
Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with diabetes mellitus.Merilog is a rapid-acting human. WEDNESDAY, Feb. 19, 2025 -- The U.S.
It’s the first time, according to the insurer, that this type of model has been used to bring a Humira biosimilar to market, and it yields a much lower cost than both the brand-name version of the drug and biologic copycats.
The biosimilar boom for provider-administered drugs continues to accelerate. Net prices in therapeutic classes with biosimilar competition have declined by 60% or more over the past few years. Some major biological reference products have now lost a majority of their unit sales to their biosimilars. drug distribution.
Biosimilars have been transforming the pharmaceutical landscape by offering cost-effective alternatives to biologic drugs. As patents for these biologics expire, the market for biosimilars is expanding rapidly, with significant implications for manufacturing technologies.
However, with the increasing competition from generic and biosimilar manufacturers, patent invalidity claims have become a significant challenge for pharmaceutical companies. In this article, we will delve into the strategies and considerations for handling drug patent… Source
European drug regulators voted for a third time not to renew the approval of Translarna. Elsewhere, Sanofi invested in a brain disease biotech and Esperion sold royalties to help pay off a loan.
BiosimilarsBiosimilars, while highly similar to their reference biopharmaceuticals, offer distinct advantages that position them as preferred therapeutic options in many cases. This is because biosimilars are not new drugs but highly similar versions of already approved therapies with established safety and efficacy profiles.
Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.
Elsewhere, AbbVie’s earnings impressed Wall Street and an FDA panel recommended changing testing requirements for some lung cancer drugs. Glycomimetics and Cue Biopharma both revealed layoffs.
The Humira biosimilar market has arrived! This month, nine biosimilar versions of adalimumab launched in the U.S. Surprisingly, two PBMs—Express Scripts and OptumRx—will each offer at least one low-list-price biosimilar option on their main national formularies. d/b/a Drug Channels Institute. Will payers let Humira go?
As regular readers know, the biosimilar boom for provider-administered drugs has been accelerating. In many therapeutic areas, biosimilars’ market share is approaching 80%. That’s when Humira, the best-selling drug in the U.S., will face multiple biosimilar competitors. d/b/a Drug Channels Institute.
Since I published the article below in July 2023 , there have been three notable market develpoments: IQVIA has reported that as as of mid-2023, there was almost no adoption of Amgen's Amjevita, the first Humira biosimilar. Boehringer-Ingelheim launched an unbranded, low WAC version of its interchangeable biosimilar.
A recent study published in JAMA Health Forum sheds light on the impact of biosimilar competition on patient out-of-pocket (OOP) costs for biologic drugs in the United States. The research,… Source
For 2023, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again increased the number of drugs they exclude from their standard formularies. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc.
As you've surely heard, Amgen has just launched Amjevita, the first non-interchangeable biosimilar of Humira. Our crazy drug channel led Amgen to launch both a high-list/high-rebate and a low-list/low-rebate version of the drug. d/b/a Drug Channels Institute. This Feed is for personal non-commercial use only.
For 2023, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again increased the number of drugs they exclude from their standard formularies. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc.
Fiza discusses the impending influx of biosimilars and its effect on manufacturers, specifically in the immunology space. To learn more, sign up for MMIT’s Immunology Biosimilars webcast. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc.
For 2024, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again each excluded 600 or more drugs from their standard formularies. This year, Humira and its 13 biosimilars will provide the most intriguing formulary drama. All rights reserved.
Steve walks us through the expected Humira biosimilars launches and discusses potential responses from payers. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc. To learn more, check out MMIT’s Strategic Launch Report & Evaluate Forecast solution.
In this issue: CVS disassociates itself from its chain pharmacy association Payers are paying attention to ICER Benefits of the biosimilar boom A fantastic takedown of health insurance deductibles Plus, I join the Advisory Board of Alto Pharmacy. d/b/a Drug Channels Institute. P.S. Join my nearly 30,000 (!) to 1:30 p.m.
The latest regulatory setback, tied to continuing manufacturing issues, ensures Alvotech and partner Teva won’t be able to launch their drug alongside a wave of emerging Humira copycats.
It's time for a super-sized Halloween roundup of wicked Drug Channels ’ tales. CVS Health frightens all but one Humira biosimilar maker away from its formulary. The gross-to-net bubble for anti-obesity GLP-1 drugs walks among us. Mark Cuban Cost Plus Drug Company conjures a partnership with Alto Pharmacy.
This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Outlook 2023. Today, I want to highlight three significant—and presumably unintended—drug channel consequences from the hastily-passed IRA legislation. d/b/a Drug Channels Institute. 117-169).
This week, I’m rerunning some popular posts while I prepare for Friday’s Drug Channels Outlook 2024 live video webinar. CVS Health has finally revealed its strategy for biosimilars of AbbVie’s Humira. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc.
CVS Health has finally revealed its strategy for biosimilars of AbbVie’s Humira. Rather than announce multiple biosimilars for its pharmacy benefit manager (PBM) formulary, the company will instead launch Cordavis, a new subsidiary that will market a private label, low-list-price version of Sandoz’ Hyrimoz.
Best known for its work in biosimilars, Coherus will acquire two drugs in human testing for various solid tumors through a roughly $65 million buyout of Surface Oncology.
Time to pack away your bathing suit, send the kids back to school, and cherish these curated curiosities that I combed from the Drug Channels coastline: Howard Dean attacks patient-unfriendly cost shifting Cancer patients’ views of copay assistance My $0.02 d/b/a Drug Channels Institute.
We organize all of the trending information in your field so you don't have to. Join 15,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content