2008 and Biosimilars - Pharmacist Digest

Michael Reilly: Congress Should Maintain Current FDA Biosimilars Standards

Safe Biologics

SEPTEMBER 27, 2024

Nearly 10 years ago, the FDA approved the first “biosimilar” – a copycat medicine highly similar, but not identical to a previously-approved biologic. Biosimilars offer new treatment choices and more price competition, increasing access and affordability for patients. But the safeguards physicians count on may soon be removed.

Biosimilars

Alteogen and Daiichi Sankyo sign license deal for ADC development

Pharmaceutical Business Review

NOVEMBER 11, 2024

” Founded in 2008, Alteogen specialises in developing biologics, including ADCs, biobetters, and biosimilars. The company’s portfolio comprises clinical-stage long-acting therapeutic proteins and next-generation ADCs developed through its platform technologies, NexP-fusion and NexMab.

Biosimilars

Roche CEO Severin Schwan to stand down after 14 years

pharmaphorum

JULY 21, 2022

The appointment might raise some eyebrows given Roche’s need to drive pharma sales as it copes with the loss of patent protection on an earlier generation of antibody-based therapies – now being hit by biosimilar competition – but Schwan is confident Schinecker is the right man to lead the company forward.

Biosimilars

Is India capable of ensuring equitable access to biopharmaceuticals?

Express Pharma

SEPTEMBER 6, 2023

In a bid to resolve both physical and financial restrictions inhibiting equitable access to quality medicines, the Jan Aushadhi scheme was launched in 2008 and envisaged the setting up of dedicated Janaushadhi Kendras to provide quality generic medicines at capped prices for the general public. appeared first on Express Pharma.

Insurance Coverage and Processing

Insurance Coverage and Processing Biosimilars Generic Medicine Drug Pricing

Silence Isn’t Golden: Two Executives Convicted in First Criminal Prosecution Under the Consumer Product Safety Act

FDA Law Blog: Biosimilars

NOVEMBER 27, 2023

Walsh — Although the Consumer Product Safety Act (CPSA) has been around for over 50 years to “protect the public against unreasonable risks of injury associated with consumer products,” it was not until 2008 that the statute was amended to authorize the Consumer Product Safety Commission (“CPSC”) to impose criminal liability against individual directors, (..)

Top 20 Drugs with US Patent Expiry in 2023 Based on Total Sales Value

PharmaShots

MARCH 29, 2023

Some companies accept the offered period and open doors to biological drugs or biosimilars. Company: Sanofi Generic Name: Plerixafor First Approval Date: Dec 15, 2008 Patent Expiration: Jul 2023 2022 Sales: $281.5M As of now, there are no the US FDA approved biosimilars available for Actemra.

Beating the Big C

Pharmaceutical Technology

JULY 23, 2008

The world’s biggest pharmaceutical company Pfizer announced in June 2008 that it would be putting its “full scope and scale” behind a push into the cancer market. “Companies used to be universally protected by patents but there is a pathway to approval opening up for biosimilar legislation. .

Pharmaceutical Companies

Pharmaceutical Companies Pharmaceutical Companies Compounding Biosimilars

New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial Review

FDA Law Blog: Biosimilars

APRIL 30, 2023

110-316 (2008) and by Section 1135 of the FDA Safety and Innovation Act (“FDASIA”), Pub. As background, FDC Act § 505(q) states that FDA shall not delay approval of a pending ANDA, 505(b)(2) application, or 351(k) biosimilar application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. 112-144 (2012).

Immunization

Immunization Immunity Biosimilars Labelling

The Future of Biopharmaceuticals in Bangladesh and India: The Five Challenges

PharmaState Academy

MAY 16, 2023

Over the next 15 to 20 years, you can expect pharma business models of today to be metamorphosed by biopharmaceuticals and biosimilars. The value of Biologics (2008), pp. Medical representatives will have to transform into knowledge workers and their upline too will have a redefined leadership role to play.

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2003-2022)

PharmaShots

APRIL 13, 2023

In 2008, Johnson acquired tissue sealing system developer, SurgRx Pfizer's pharmaceutical segment revenue increased after the acquisitions of Serenex, Encysive Pharmaceuticals, CovX, and Coley Pharmaceuticals Novartis reported a total revenue of $41.4B, under which, its pharmaceutical division faced a revenue loss of $2.6B

The Future for Biotesting

Pharmaceutical Technology

SEPTEMBER 10, 2008

As far as human pharmaceuticals are concerned, both new chemical entities and so-called “biosimilars” are included, while in veterinary drugs most demand is for modified, as opposed to reference, drugs. Biotest will be exhibiting at CPhI Worldwide 2008 between 30 September and 2 October, Messe Frankfurt, Germany.

Vaccines

Vaccines Biosimilars

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 1)

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

Our last two PTE-related posts concerned the issues of: (1) multiple PTEs—a topic we blogged on in 2020 , but that we have been following since the very early days of the FDA Law Blog in 2008 and 2009 (see our previous posts here , here , and here )—and (2) the Improving Regulatory Transparency for New Medical Therapies Act (“IRTNMTA”)—a topic we blogged (..)

Controlled Substances

Controlled Substances Hospitals

FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog: Biosimilars

AUGUST 21, 2023

As FDA explained in a 2008 Rulemaking , FDA’s existing policies are “intended to ensure that scientifically valid and appropriately worded warnings will be provided in the approved labeling for medical products, and to prevent overwarning, which may deter appropriate use of medical products, or overshadow more important warnings.”

Labelling

Labelling Vaccines Communication

ASBM’s Comments on the Medicare Drug Price Negotiation Plan: Protecting Patients and Ensuring Access to Medicines

Safe Biologics

APRIL 25, 2023

Having served in the Department of Health and Human Services’ Office of the Secretary from 2002-2008, including two years as Associate Deputy HHS Secretary, I participated in the development and implementation of Medicare Part D, the program’s prescription drug benefit.

Drug Pricing

Drug Pricing Biosimilars Vaccines

ASBM’s Comments on the Medicare Drug Price Negotiation Plan: Protecting Patients and Ensuring Access to Medicines

Safe Biologics

APRIL 25, 2023

Having served in the Department of Health and Human Services’ Office of the Secretary from 2002-2008, including two years as Associate Deputy HHS Secretary, I participated in the development and implementation of Medicare Part D, the program’s prescription drug benefit.

Drug Pricing

Drug Pricing Biosimilars Vaccines

Will Epygen’s biosimilars bets pay off?

Express Pharma

JANUARY 3, 2025

While India was able to leverage the 2008 patent cliff of small molecules, the same playbook will not work for biologics and biosimilars. Many biopharma companies in India have already leveraged the biosimilar patent cliff. Biocon became the first company from India to launch its biosimilar Hulio in the US in July 2023.

Biosimilars

Biosimilars Vaccines Diabetes

It’s a Three-Peat: DEA and HHS Extend Telemedicine Flexibilities Until December 31, 2025

FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

temporary exceptions from some of the requirements of the Ryan Haight Act of 2008) are extended for an additional year, until December 31, 2025. The federal telemedicine flexibilities (i.e., Thus, while continuing to review industry feedback, DEA is still working on promulgating a more workable final set of telemedicine regulations.

Controlled Substances

Pharmacist Digest

Michael Reilly: Congress Should Maintain Current FDA Biosimilars Standards

Alteogen and Daiichi Sankyo sign license deal for ADC development

Trending Sources

Roche CEO Severin Schwan to stand down after 14 years

Is India capable of ensuring equitable access to biopharmaceuticals?

Silence Isn’t Golden: Two Executives Convicted in First Criminal Prosecution Under the Consumer Product Safety Act

Top 20 Drugs with US Patent Expiry in 2023 Based on Total Sales Value

Beating the Big C

New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial Review

The Future of Biopharmaceuticals in Bangladesh and India: The Five Challenges

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2003-2022)

The Future for Biotesting

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 1)

FDA-Approved Labeling: Is Enough Enough?

ASBM’s Comments on the Medicare Drug Price Negotiation Plan: Protecting Patients and Ensuring Access to Medicines

ASBM’s Comments on the Medicare Drug Price Negotiation Plan: Protecting Patients and Ensuring Access to Medicines

Will Epygen’s biosimilars bets pay off?

It’s a Three-Peat: DEA and HHS Extend Telemedicine Flexibilities Until December 31, 2025

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