Safe Biologics

MAY 5, 2023

On April 30th, the Generics and Biosimilar Initiative (GaBI) published a meeting report on a 2-hour webinar entitled “Non-Medical Switching of Biologicals and Biosimilars: Canada, Europe, and the US”, hosted July 20th, 2022 by ASBM and GaBI. Watch video of the webinar here.

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Biosimilars 100

Safe Biologics

JULY 13, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE.

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Safe Biologics

JULY 13, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE.

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Safe Biologics

NOVEMBER 30, 2023

In November, ASBM released two fact sheets on interchangeable biosimilars. Download them here: Physician Perspectives on Interchangeable Biosimilars Interchangeable Biosimilars: Comparing Europe and the U.S.

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Biosimilars 130

Drug Channels

MARCH 5, 2024

Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s latest live video webinar: Drug Channel Implications of the Inflation Reduction Act This event will be broadcast live on Friday, April 5, 2024, from 12:00 p.m. This event is part of The Drug Channels 2024 Video Webinar Series.

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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. The webinar will be broadcast from the Drug Channels studio in beautiful downtown Philadelphia. (Or,

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Big Molecule Watch

NOVEMBER 7, 2023

This webinar will explore topics including: Evolving trends of biologic patent challenges at the PTAB; Strategic considerations for biosimilar manufacturers; and Lessons learned from recent filings. Click here to register for the webinar.

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Biosimilars 67

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. The webinar will be broadcast from the Drug Channels studio in beautiful downtown Philadelphia. The webinar will last 90 minutes to accommodate audience questions.

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Drug Channels

SEPTEMBER 7, 2022

As regular readers know, the biosimilar boom for provider-administered drugs has been accelerating. In many therapeutic areas, biosimilars’ market share is approaching 80%. will face multiple biosimilar competitors. The video is excerpted from last month’s Specialty Drugs Update: Trends, Controversies, and Outlook video webinar.

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Biosimilars 86

Drug Channels

APRIL 3, 2024

This week, I’m rerunning some popular posts while I prepare for Friday’s live video webinar: Drug Channel Implications of the Inflation Reduction Act. The 2024 formularies described below should boost biosimilar adoption. This year, Humira and its 14 biosimilars will provide the most intriguing formulary drama.

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Biosimilars 52

Drug Channels

DECEMBER 11, 2023

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. Click here to see the original post from September 2023.

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Putting Patients First Blog

MAY 26, 2023

Biosimilars briefing Event Time: 2:00 - 3:00 p.m. ET Event Location: Virtual The National Health Council invites you to join us for a webinar on the latest developments with biosimilars on Monday, June 12 at 2 p.m. This briefing will focus on the value biosimilars hold for patient communities and our health care system.

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Big Molecule Watch

OCTOBER 5, 2023

The world of biosimilar litigation is back in full swing with several BPCIA lawsuits currently pending. Click here to register for the webinar. The post Patent Dance Disclosures and Beyond: Recent Biosimilars Litigation at the District Court appeared first on Big Molecule Watch.

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Biosimilars 67

Drug Channels

MARCH 28, 2023

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. Below, I highlight four takeaways from this year’s lists, including a look at biosimilar insulin and the forthcoming biosimilar competition for Humira.

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Biosimilars 95

Safe Biologics

DECEMBER 3, 2023

ASBM and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars On November 30, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted I nterchangeable Designation for Biosimilars- Ensuring Continuity of Patient Care: Upholding Interchangeability Status for Biosimilars.

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Big Molecule Watch

SEPTEMBER 7, 2023

Developing and successfully commercializing a biosimilar is a complex and expensive process. Click here to register for the webinar. The post So You Want To Make A Biosimilar: Top Considerations Before BLA Submission appeared first on Big Molecule Watch.

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Biosimilars Labelling 57

Safe Biologics

JULY 20, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE.

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Biosimilars Drug Pricing Drug Development 130

Safe Biologics

JULY 20, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE.

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Biosimilars Drug Pricing Drug Development 130

Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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Drug Channels

DECEMBER 12, 2022

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Outlook 2023. During Friday’s webinar, I’ll be sharing my updated thoughts about the IRA’s impact on manufacturers, Part D plans, and patient behavior. Click here to see the original post and comments from September 2022.

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Drug Channels

SEPTEMBER 8, 2021

Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for his latest video webinar: Drug Channels Update: Buy-and-Bill Market Trends. This event is part of The Drug Channels 2021 Quarterly Video Webinar Series. The webinar will be 90 minutes to accommodate audience questions.

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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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Biosimilars 85

Drug Channels

NOVEMBER 15, 2021

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 2022. This event is part of The Drug Channels 2021 Quarterly Video Webinar Series. The Outlook 2022 marks our third annual outlook webinar. Broadcast live on December 17, 2021.

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Specialty Pharmacies Drug Pricing Biosimilars 66

Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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Safe Biologics

NOVEMBER 12, 2023

View the full webinar here or watch individual segments linked below. 6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable” Under U.S. ASBM surveys of U.S.

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Drug Channels

DECEMBER 17, 2020

This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Drug Channels Outlook 2021. Conveniently for HHS, ASPE's analysis stopped before the biosimilar boom began. The biosimilar market is finally beginning to fulfill its promise. Drug pricing perceptions always seem to lag reality.

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Biosimilars Drug Pricing 52

Safe Biologics

FEBRUARY 1, 2024

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability.

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Drug Channels

JULY 20, 2022

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. Cut through the steamy summer haze with our refreshing selection of articles and insights.

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Biosimilars 79

Safe Biologics

JANUARY 12, 2024

The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe. Oregon state law currently only permits biosimilars that the FDA has approved as interchangeable to be automatically substituted.

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Biosimilars Drug Pricing 130

Safe Biologics

DECEMBER 6, 2023

prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber. and worldwide.”

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FDA Law Blog: Biosimilars

MAY 22, 2023

HP&M”) invites you to join Director Larry Houck for a free webinar demystifying DEA inspections by providing an understanding of controlled substance accountability audits, the importance of conducting mirror reviews, and mock DEA-style internal inspections. Hyman, Phelps & McNamara, P.C. (“HP&M”)

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Controlled Substances 40

Drug Channels

APRIL 19, 2022

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: PBM Industry Update: Trends, Controversies, and Outlook. An ironic postcript: Less than two months after my article was published, Cigna CEO David Cordani bragged about the cost savings from "aggressive adoption" of biosimilars.

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Biosimilars Drug Pricing 76

FDA Law Blog: Biosimilars

MAY 3, 2023

HP&M”) invites you to join Director Larry Houck for a free webinar demystifying DEA inspections by providing an understanding of controlled substance accountability audits, the importance of conducting mirror reviews and mock DEA-style internal inspections. The webinar will share additional valuable inspection tips.

Controlled Substances 52

Controlled Substances 52

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. I recommend that you follow me on LinkedIn, because the quality of comments is much higher than they are on Twitter.) to 1:30 p.m.

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Hospitals Biosimilars 77

Safe Biologics

DECEMBER 8, 2022

ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP gave a presentation entitled “Key Factors for Improving Sustainability in Biosimilar Markets”. The presentation reflected the findings from a recent webinar ASBM held on this subject with GaBI Journal. Read the GaBI Journal report of the webinar here.

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Biosimilars Communication Drug Development 100

Safe Biologics

FEBRUARY 1, 2024

In January, the Generics and Biosimilars Initiative (GaBI) published a whitepaper entitled “ Medicare Drug Price Negotiations: Impact on Healthcare Development and Patient Access to Medicines” The paper’s content is drawn from a webinar on the same topic hosted by ASBM and GaBI on July 26, 2023.

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Drug Pricing Biosimilars 100

FDA Law Blog: Biosimilars

SEPTEMBER 12, 2023

In this webinar you’ll learn: How employees diverted controlled substances — their methods are constantly evolving What red flags were missed DEA inspection priorities Safeguards to minimize internal diversion Best practices for maximizing diversion detection Mr.

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Controlled Substances Hospitals 49