2003 and Biosimilars - Pharmacist Digest

STAT+: Boehringer Ingelheim layoffs are a sign of dysfunctional Humira biosimilar market

STAT

APRIL 4, 2024

WASHINGTON — Boehringer Ingelheim is laying off or relocating its sales staff for its Humira biosimilar Cyltezo in a sign of how difficult it’s been to get drug middlemen to adopt less-expensive versions of the blockbuster, the company confirmed. List prices of Humira biosimilars are as much as 85% lower.

Biosimilars

Biosimilars Drug Pricing

The Issue with Reissue: PTE Edition

FDA Law Blog: Biosimilars

MARCH 18, 2025

Merck applied for a patent term extension on the reissued patent, claiming the start of the regulatory review period as April 2004 and termination at the approval of the BRIDION NDA in December 2015.

Drug Pricing

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies

FDA Approves XOLAIR to Treat Children and Adults With One or More Food Allergies

Big Molecule Watch

FEBRUARY 21, 2024

XOLAIR was initially approved by the FDA in 2003. Food and Drug Administration (FDA) approved XOLAIR (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with Immunoglobulin E (IgE)-mediated food allergy.

Biosimilars

To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

The closest FDA has come is in a 2003 preamble noting that patents that claim finished dosage forms—which can include “metered aerosols, capsules, metered sprays, gels, and pre-filled drug delivery systems”—should be listed in the Orange Book, suggesting that a patent that claims both the drug substance and the delivery device should be listed.

Communication

Communication Dosage Biosimilars

First Drugs Selected for Price Negotiations Under The Inflation Reduction Act To Be Announced Next Week: A Recap of What That Means – The Drug Price Negotiation Program and Pending Legal Challenges

Big Molecule Watch

AUGUST 25, 2023

Congress left Medicare drug pricing to the drug manufacturers, pharmacies, and insurance plan sponsors to determine, and expressly prohibited the government from “interfering” in those private price negotiations under the so-called “Non-Interference Clause” of the Medicare Modernization Act of 2003.

Drug Pricing

Drug Pricing Biosimilars Insurance Coverage and Processing Labelling

Top Performing Drug – Enbrel (June Edition)

PharmaShots

JUNE 28, 2023

Some of the alternative drugs for Enbrel include: Enbrel’s Biosimilars6 As Enbrel has a long journey in the market it is already facing competition from biosimilars in the US and other countries. Some of its approved biosimilars are mentioned below along with the regulatory bodies they are approved by*. Clinicaltrial.gov 4.

An Offer You Can’t Refuse: Merck Attacks Medicare Negotiation Program as an Unconstitutional Taking

FDA Law Blog: Biosimilars

JUNE 7, 2023

With the IRA Negotiation Program, Congress jettisoned the voluntary agreement approach in all but name.

Communication

Drugs Companies Clap Back at Congress…Then Get Sued

FDA Law Blog: Biosimilars

MARCH 12, 2024

Both Congress and FTC seem to have spun this tale that the named drug companies have been intentionally abusing the Orange Book patent listing requirements by including device patents in the Orange Book, but it’s really important to note that until FTC took the unusual step of requesting delisting in Fall 2023, FDA not only had provided no guidance (..)

Dosage

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

2003) , and Biogen lnt’l v. The PTO’s not-even-specious-argument, citing what certainly appears to us to be absolutely irrelevant case law, such as Novartis AG v. Ezra Ventures LLC, 909 F.3d 3d 1367 (Fed. 2018) , Arnold Partnership v. Rogan , 246 F. 2d 460 (E.D. Banner Life Sciences LLC, 956 F.3d 3d 1351 (Fed.

Controlled Substances

Controlled Substances Hospitals

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

PharmaShots

APRIL 13, 2023

Through the inclusion of Pharmacia’s products along with a strong performance, Pfizer’s pharmaceutical and animal health revenue was boosted by 40% and 43% respectively In the year 2003, Johnson & Johnson generated a revenue of $41.9B which depicted a growth of 15.3% as compared to the previous year. from last year.

Decades Later, Congress Continues Debating the Preserve Access to Affordable Generics (and Biosimilars) Act; But will the Recent Jarkesy SCOTUS Decision Finally Put an End to the Insanity?

FDA Law Blog: Biosimilars

AUGUST 29, 2024

Shumsky — As readers of this blog know ( see, e.g. , here ), the Affordable Generics (and Biosimilars) Act has been floating around in Congress for the better part of two decades. The latest iteration of the Preserve Access to Affordable Generics and Biosimilars Act making its way through Congress is Senator Amy Klobuchar’s (D-MN) S.

Biosimilars

Beating the Big C

Pharmaceutical Technology

JULY 23, 2008

” “Between 2003 and 2005 global sales for cancer-treating drugs grew by 40%.” ” Looming biosimilar legislation and the disregard for patents in the developing world is also threatening the intellectual property, and therefore profit margins, of companies looking to develop cancer drugs.

Pharmaceutical Companies

Pharmaceutical Companies Pharmaceutical Companies Compounding Biosimilars

A history of Johnson & Johnson

pharmaphorum

FEBRUARY 26, 2021

Beginning in 2003, J&J became involved in a series of litigations with Boston Scientific involving patents covering heart stent medical devices. Cordis was founded in Miami in 1959 and develops and produces medical equipment to treat patients who suffer from cardiovascular disease. CEO Alex Gorsky, who was appointed in 2012.

Vaccines

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. The earliest tenured is John Bartels, who served as Administrator from 1973 to 1975.

Controlled Substances

Controlled Substances Chemotherapy Compounding

FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

FDA Law Blog: Biosimilars

JANUARY 9, 2024

After its enactment in 2003, successive administrations thwarted its implementation by declining to certify to Congress that importation will pose no additional risk to public health and safety and will result in a significant reduction in cost to American consumers, as the statute requires.

Pharmacist Digest

STAT+: Boehringer Ingelheim layoffs are a sign of dysfunctional Humira biosimilar market

The Issue with Reissue: PTE Edition

Trending Sources

FDA Approves XOLAIR to Treat Children and Adults With One or More Food Allergies

To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

First Drugs Selected for Price Negotiations Under The Inflation Reduction Act To Be Announced Next Week: A Recap of What That Means – The Drug Price Negotiation Program and Pending Legal Challenges

Top Performing Drug – Enbrel (June Edition)

An Offer You Can’t Refuse: Merck Attacks Medicare Negotiation Program as an Unconstitutional Taking

Drugs Companies Clap Back at Congress…Then Get Sued

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)

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

Decades Later, Congress Continues Debating the Preserve Access to Affordable Generics (and Biosimilars) Act; But will the Recent Jarkesy SCOTUS Decision Finally Put an End to the Insanity?

Beating the Big C

A history of Johnson & Johnson

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

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