pharmaphorum

OCTOBER 28, 2022

She is an SME in market access, rare disease and biosimilars. Alongside his work as a recognised author, speaker, moderator and industry advisor, he founded the industry-leading publication pharmaphorum in 2009. Nina Pinwill BSc (Hons) MSc DIC, is the Head of Commercial Operations at NHS England and NHS Improvement.

Biosimilars 122

Biosimilars 122

Express Pharma

SEPTEMBER 6, 2023

Known as biosimilars, these biopharma products are highly similar to innovator products and have no clinically meaningful dissimilarities, especially in terms of efficacy, safety or quality. Indian pharma players could play a key role in positioning biosimilars as superior products to costly biologics.

Insurance Coverage and Processing 59

Insurance Coverage and Processing Biosimilars Generic Medicine Drug Pricing 59

European Pharmaceutical Review

DECEMBER 20, 2023

Changes to regulatory data protection periods are of particular interest to biopharma” Changes to regulatory data protection (RDP) periods are of particular interest to biopharma (originators and generic / biosimilar manufacturers). By contrast, orphan drugs could become less profitable, more risky investments. Internet] 2023.

Biosimilars 98

Biosimilars Labelling Documentation 98

FDA Law Blog: Biosimilars

MARCH 7, 2024

Sasinowski — In 2009 — 15 years ago — the National Organization for Rare Disorders (NORD) announced the first U.S. In 2009 I served as Chair of NORD and through the hard work of countless colleagues we inaugurated the first Rare Disease Day. By Frank J. recognition of Rare Disease Day.

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PharmaShots

JUNE 2, 2023

Impact Therapeutics Entered into a License and Collaboration Agreement with Eikon Therapeutics to Develop and Commercialize IMP1734 Date: June 02, 2023 | Tags: Impact Therapeutics, Eikon Therapeutics, IMP1734, Pharma, China, Hong Kong, Macau, Taiwan BMS’ Mavacamten Receives the NICE Recommendation for the Treatment of Obstructive Hypertrophic (..)

Biosimilars 40

Biosimilars 40

Eye on FDA

FEBRUARY 10, 2021

Heightened Role for “Bad Ad Program” – A recent interview with the new Acting Director of OPDP revealed that a primary focus for the office this past year was in relation to the biosimilars market. It was also noted that the “ Bad Ad ” program turned 10 years old this year.

Communication 77

Communication Biosimilars Compounding 77

FDA Law Blog: Biosimilars

JANUARY 15, 2024

This story goes back to the 2009 Family Smoking Prevention and Tobacco Control Act, which prohibits manufacturers from selling any “new tobacco product” without authorization from FDA.

Documentation 115

Documentation 115

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP).

Labelling 64

Labelling Communication 64

PharmaShots

JUNE 28, 2023

In 2009, Pfizer acquired Wyeth thus seeking the rights to Enbrel. 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. Enbrel biosimilars Gabionline.net Centerforbiosimilars.com 7.

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Biosimilars Insurance Coverage and Processing Dosage Compounding 40

European Pharmaceutical Review

DECEMBER 22, 2022

2017 Aug 1;28(8):2009-2012. 2N-Glycan Analysis: Rapid preparation and screening of biosimilar candidates by LC/MS and CE. Available at: doi.org/10.1016/j.ctrv.2021.102240. 2021.102240. Friberg G, Reese D. Blinatumomab (Blincyto): lessons learned from the bispecific t-cell engager (BiTE) in acute lymphocytic leukemia (ALL).

Biosimilars 98

Biosimilars Immunization Immunity Drug Development 98

FDA Law Blog: Biosimilars

AUGUST 12, 2024

While FDA had acknowledged this approach, in its 2022 remand decision FDA said that such approach was an “improper application” of the regulation and that the Agency started differentiating the opening of the INAD file from submission of an NCIE in 2009. Thus, the Agency concluded, the June 2011 date should stand.

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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 59

Controlled Substances Hospitals 59

PharmaShots

JUNE 7, 2023

Our team at PharmaShots has summarized 16 key events of the biosimilar space of May 2023 1. Sandoz Reports Real World Study Results of GP2013 (biosimilar, rituximab) for the Treatment of Rheumatoid Arthritis Date- May 08, 2023 Product: GP2013 (biosimilar, rituximab) The study incl. 84% vs 64%) & 2yr. (60%

Biosimilars 40

Biosimilars Packaging Diabetes Pharmaceutical Companies 40

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 59

Biosimilars 59

PharmaShots

MARCH 29, 2023

Some companies accept the offered period and open doors to biological drugs or biosimilars. As of now, there are no the US FDA approved biosimilars available for Actemra. However, last August, Fresenius Kabi announced the US FDA's acceptance of its biosimilar BLA, bringing a potential candidate into the market before long.

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Biosimilars Diabetes Chemotherapy Immunization 49

FDA Law Blog: Biosimilars

JANUARY 22, 2025

And in all seriousness, the finalization of this guidance is somewhat historic given that industry has been relying on various versions of draft Good Reprint Practices guidance since 2009. This final guidance (16 years in the making!)

Labelling 59

Labelling Communication 59

FDA Law Blog: Biosimilars

FEBRUARY 4, 2025

In the eleven years from 2009 to the end of 2019, FDA awarded 11 tropical disease PRVs for the development of therapies for diseases such as malaria, tuberculosis, dengue, and river blindness. See Table 1. As of the start of 2025, tropical PRVs represent less than 20% of all the PRVs granted.

Vaccines 52

Vaccines 52

PharmaShots

APRIL 13, 2023

2009 was a challenging year for multinational companies due to the recession and currency fluctuations Johnson & Johnson's performance graph declined by 2.9% Despite a challenging year, Johnson & Johnson acquired Cougar and Elan Pfizer's 2009 performance was significant as compared to 2008 with the addition of Wyeth.

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Biosimilars Vaccines Pharmaceutical Companies Pharmaceutical Companies 40

pharmaphorum

DECEMBER 2, 2020

Since the turn of the millennium, Pfizer has embarked on a series of mega-mergers, gobbling up Warner-Lambert in 2000, Pharmacia and Upjohn in 2002, Wyeth in 2009, and Medivation in 2016. Like most pharma companies of its size, Pfizer has faced its fair share of controversy as one of the most well-known drugmakers in the world.

Compounding 128

Compounding Vaccines Biosimilars Diabetes 128

pharmaphorum

FEBRUARY 26, 2021

The litigation was settled in 2009, when Boston Scientific agreed to pay $716 million in September and an additional $1.73 But like many of its big pharma peers, it faces increased pressure on some of its biggest brands, as expiring patents pave the way for generic competition while biosimilars undercut sales of biologics.

Vaccines 126

Vaccines Biosimilars Labelling Communication 126

Express Pharma

DECEMBER 18, 2024

Key companies like Celltrion and Samsung Bioepis dominate the biosimilars market, contributing significantly to the approvals and pipelines. Celltrions strong presence in deal-making further underscores South Koreas growing influence in the global biosimilars landscape, reveals GlobalData.

Biosimilars 104

Biosimilars 104

pharmaphorum

JANUARY 5, 2021

In 2009, $183m of global market value was due to go off patent in the next five years, in 2019, it was $200m. Similar gross figures, but the 2009 figure accounted for 30% of global market value, and 89% of the patent loss was small molecules. Even if they do, however, their savings will be lower. About the author.

Hospitals 105

Hospitals Vaccines Pharmaceutical Companies Pharmaceutical Companies 105

FDA Law Blog: Biosimilars

APRIL 6, 2025

By way of background, when FDA issued its rule in 2016 that deemed e-cigarettes and e-liquids to be tobacco products subject to regulation under the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA), it required manufacturers of these products to obtain marketing authorization by submitting a premarket tobacco product application for (..)

Documentation 59

Documentation 59

pharmaphorum

FEBRUARY 5, 2021

The FDA has developed in line with the life sciences industry during Woodcock’s time and has kept pace with development of innovations such as cancer cell therapies, biosimilars and digital therapeutics. But with the interim post seen as an audition for the permanent role, things have not got off to a good start for Woodcock.

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Vaccines Biosimilars Labelling 119

FDA Law Blog: Biosimilars

FEBRUARY 12, 2025

For some background (which is covered in more detail in one of our previous posts on the subject ), in 2009, Congress specifically exempted tobacco or menthol when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)s Special Rule for Cigarettes. 111-58, at 38-39 (2009).

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