DrugBank

SEPTEMBER 26, 2024

Biosimilars  Biosimilars, 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.

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Drug Channels

OCTOBER 31, 2023

CVS Health frightens all but one Humira biosimilar maker away from its formulary. Mark Cuban Cost Plus Drug Company conjures a partnership with Alto Pharmacy. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. The gross-to-net bubble for anti-obesity GLP-1 drugs walks among us. Penn Medicine gorges on the 340B program.

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Drug Channels

NOVEMBER 9, 2022

Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for a new live video webinar: Drug Channels Outlook 2023. Join Dr. Fein as he helps you and your team get ready for 2023 by outlining key issues and uncertainties that will surely affect your planning. to 1:30 p.m. WHAT YOU WILL LEARN.

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Drug Channels

JULY 11, 2022

Informa Connect's Hub and Specialty Pharmacy Models West. September 14-15, 2022 Sheraton San Diego Hotel & Marina | San Diego, CA www.informaconnect.com/hub-specialty-pharmacy-west. Delivered as a Hybrid Event. Drug Channels readers will save 10% off the current registration rate when they use code 22DC10 *.

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Drug Channels

DECEMBER 11, 2023

Click here to see the original post from September 2023. CVS Health has finally revealed its strategy for biosimilars of AbbVie’s Humira. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. This week, I’m rerunning some popular posts while I prepare for Friday’s Drug Channels Outlook 2024 live video webinar.

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Drug Channels

SEPTEMBER 6, 2023

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.

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Drug Channels

MAY 30, 2023

Speaking of PBMs, be sure to join me for my new live video webinar, PBMs and the Battle Over Patient Support Funds: Accumulators, Maximizers, and Alternative Funding , on June 23, 2023, from 12:00 p.m. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. Summer unofficially began over the weekend. to 1:30 p.m.

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Drug Channels

MARCH 30, 2023

This week, I’m rerunning some popular posts while I prepare for tomorrow’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. So far, it appears that PBMs are neither preferring Amgen's Humira biosimilar nor embracing the low-list/low-rebate version.

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Drug Channels

APRIL 25, 2023

While we wait for the Phillies turnaround, let’s oil up our gloves, lace up our cleats, and run the bases around this month's biggest hits: Foul ball : OptumRx prefers higher prices for the first Humira biosimilar Strikeout : Copay accumulators hurt health equity Bench warmer : Surprise? d/b/a Drug Channels Institute.

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Drug Channels

JANUARY 27, 2023

Saket discusses market access and contracting strategies for medical benefit products when pharmacy benefit biosimilar therapies launch. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. He then describes how to automate formulary and medical policies to protect manufacturers from overpayment.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. 11, 2023 ( DOJ Press Release ). 11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ).

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Drug Channels

NOVEMBER 14, 2023

Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s new live video webinar: Drug Channels Outlook 2024 This event will be broadcast live on Friday, December 15, 2023 12:00 p.m. This event is part of The Drug Channels 2023 Video Webinar Series. to 1:30 p.m.

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Drug Channels

JUNE 27, 2023

on the Humira price war—and the role of cost-plus pharmacy pricing Fresh evidence that formulary exclusions hurt patients Disturbing oncology drug benefit management Plus, an entertaining explanation of why the U.S. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. Happy 247st birthday, America! d/b/a Drug Channels Institute.

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Drug Channels

MARCH 5, 2024

WHAT YOU WILL LEARN In 2023, the Inflation Reduction Act of 2022 (IRA) began to alter the Medicare Part D program and trigger changes in beneficiary out-of-pocket spending, drug prices, pharmacy economics, and market access strategies. Pharmacies and Pharmacy Benefit Managers.

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Drug Channels

APRIL 3, 2024

The 2024 formularies described below should boost biosimilar adoption. As a new Biosimilar Council report shows , Humira retained 99% of market share in late 2023, despite being more expensive than its biosimilars. This year, Humira and its 14 biosimilars will provide the most intriguing formulary drama.

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FDA Law Blog: Biosimilars

MAY 30, 2024

Initially, drug manufacturers were required to offer these discounts only to the in-house pharmacies of covered entities. In 2010, the Health Resources and Services Administration (HRSA) authorized covered entities to contract with an unlimited number of retail pharmacies to fill prescriptions for their patients.

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Drug Channels

NOVEMBER 29, 2022

In this issue: Mark Cuban schools Elon Musk on PBMs Market access lessons from Semglee Gen Z rejects the pharmacy career path A potent call for 340B transparency Plus, get ready to love the ‘90s again! Please join me for my upcoming live video webinar, Drug Channels Outlook 2023 , on December 16, 2022, from 12:00 p.m. to 1:30 p.m.

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Drug Channels

JUNE 5, 2023

thINc’s Specialty Networks and Patient Support Services Summit In-Person Event | August 29-30, 2023 Lowes Philadelphia, Philadelphia, PA www.thinc360.com/specialty Copyright © 2006-2023 Pembroke Consulting, Inc. com/specialty Early rates are in effect. Use promo code DC5123 to save an additional $100 off the early rates.

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FDA Law Blog: Biosimilars

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103). Decision at 8-9.

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Drug Channels

OCTOBER 23, 2023

Informa Connect’s Trade and Channel Strategies Hybrid Event | December 11-13, 2023 DoubleTree By Hilton | Philadelphia, PA Exclusive Offer–Be sure to use your exclusive promo code 23DC10 to save 10% off* of your registration. Copyright © 2006-2023 Pembroke Consulting, Inc. What can you expect? Drug Channels, or any of its employees.

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Pharmacy Biosimilars Marketing Production 75

Drug Channels

JUNE 26, 2023

Drug Channels readers will save 10% off when they use code 23DRCH10 and register prior to July 28, 2023.* Join your colleagues on August 14-16, 2023 at the Westin Copley Place for the Health Systems & Pharma Partnering Summit to optimize strategic partnerships and improve quality, manage costs and enhance patient outcomes.

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”). 16, 2023 ( DOJ Press Release ). 21 U.S.C. §

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Drug Channels

SEPTEMBER 12, 2023

On October 10, 2023, Drug Channels Institute will release 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2023-24 edition at special discounted prices. pharmaceutical distribution industry.

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FDA Law Blog: Biosimilars

JANUARY 22, 2024

OCs recent 2023 Annual Report—covering the fiscal year from October ’22 to September ’23—puts some meat on the bones of those issues and describes how OC touches almost every area of enforcement that CDER undertakes. Select Graphics and Charts from Office of Compliance 2023 Annual Report ( here and here ) Drug Supply Chain.

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FDA Law Blog: Biosimilars

JULY 31, 2023

Now, in July 2023, DEA has finally issued its final rule amending its regulations for partial filling of prescriptions for schedule II substances. 46,983 (July 21, 2023). Pharmacists could partially fill a schedule II prescription if the pharmacy is unable to supply the full quantity of a written or emergency oral prescription.

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FDA Law Blog: Biosimilars

MARCH 27, 2023

So, what is special about September 24, 2023? For the stakeholders who use UPC as their device identifier, UDI alternatives UDI-A160001 and UDI-A16002 will expire on September 24, 2023. Devices that are manufactured and/or labeled on or after September 24, 2023, cannot use this alternative.” Emphasis added.)

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FDA Law Blog: Biosimilars

AUGUST 9, 2023

Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. Instead, the patient must request that the prescriber send a new prescription to a different pharmacy. 48365, 48369 (July 27, 2023).

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FDA Law Blog: Biosimilars

MAY 13, 2024

RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy data, and feedback from wearables and mobile technology. RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.”

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FDA Law Blog: Biosimilars

JUNE 27, 2024

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. Coconut Grove Pharmacy; Decision and Order, 89 Fed. Gulf Med Pharmacy; Decision and Order, 86 Fed. 72,694, 72,703 (Dec.

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

Rescheduling out of schedule I would allow for the medical use of FDA-approved prescription drugs dispensed by DEA-registered, state licensed pharmacies pursuant to prescriptions issued by similarly DEA-registered, state licensed practitioners. and lack accepted safety for use under medical supervision. 21 U.S.C. § 812 (b)(1). 53,688 (Aug.

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FDA Law Blog: Biosimilars

MARCH 29, 2023

Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. According to this announcement, FDA approval of RiVive is anticipated in July 2023 and the U.S. By Kalie E. launch would be in early 2024.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance. before such manufacturer signs a Discount Program agreement) and non-binding of their phase-in eligibility if they provide CMS all ownership information by December 8, 2023.

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Drug Channels

OCTOBER 10, 2023

I am pleased to announce our new 2023–24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. The notable new material in this 2023-24 edition includes: New data about commercial pricing and reimbursement for provider-administered biosimilars appears in Section 3.2.2.

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FDA Law Blog: Biosimilars

SEPTEMBER 12, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

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FDA Law Blog: Biosimilars

SEPTEMBER 26, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

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Hospitals Pharmacy Compliance Government 45