pharmaphorum

FEBRUARY 18, 2022

Xolair (omalizumab) has been a mainstay of treatment for years, and approval for the condition in 2014 was responsible for a leap in revenues for the drug – originally developed for a form of severe asthma – to blockbuster levels. Novartis reported $1.4 billion from the drug. .

Biosimilars 105

Biosimilars 105

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.

Biosimilars 98

Biosimilars Labelling Documentation 98

pharmaphorum

DECEMBER 15, 2022

” Since 2014, the repayment percentage detailed in the VPAS and predecessor the PPRS average at around 7%, before skyrocketing to 19% in 2022 ahead of a government agreed cap at 15%. “The industry now regards the current approach, due to end in 2023, as broken.” The increase to 26.5% VPAS tax on top.

Biosimilars 72

Biosimilars 72

FDA Law Blog: Biosimilars

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

Drug Development 64

Drug Development Communication Labelling 64

RX Note

DECEMBER 11, 2023

Examples Amphotericin B Doxorubicin Doxycycline Pegfilgrastim and biosimilars Phytonadione Selexipag Sodium nitroprusside Thiotepa - subject to manufacturer External Links Light-sensitive injectable prescription drugs, 2014 Light-Sensitive Injectable Prescription Drugs, 2022

Packaging 40

Packaging Biosimilars 40

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). The SIUU Guidance, which supersedes the 2014 Draft GRP Guidance, is not substantially different in that regard and contains similar information as to the types of disclosures previously recommended.

Labelling 64

Labelling Communication 64

European Pharmaceutical Review

JANUARY 18, 2024

When considering the expense of ERTs and SRTs, where biosimilars face difficult market penetration due to strict regulations, this will slow market growth. GlobalData’s Analyst covering Neurology and Ophthalmology, Thomas Parker, MPharmacol, predicted that Belsomra would lead the market by 2023.

Drug Pricing 98

Drug Pricing Biosimilars Compounding 98

European Pharmaceutical Review

FEBRUARY 22, 2023

In 2023, Rani Therapeutics plans to begin three additional Phase I studies with pipeline molecules RT-105 (containing an adalimumab biosimilar), RT-110 (containing PTH for hypo-parathyroidism) and RT-111 (containing an ustekinumab biosimilar for psoriatic arthritis, ulcerative colitis, Crohn’s disease and psoriasis).

Biosimilars 105

Biosimilars Diabetes Immunity Immunization 105

pharmaphorum

NOVEMBER 17, 2022

The 2019 VPAS , just like its predecessor that was in place from 2014, has at its heart a payback mechanism. One of those is Celltrion Healthcare, which says that it is no longer viable to continue to supply the NHS with biosimilars. Predictable for government. The other company is not named.

Biosimilars 98

Biosimilars 98

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

We recount a few milestones along the road here: 1997 ASR Rule restricts sale, distribution of analyte specific reagents; FDA asserts authority over LDTs but articulates enforcement discretion policy 1998 FDA denies Citizen Petition submitted in 1992 on behalf of several clinical laboratories challenging agency authority over “home brew” tests 2006 (..)

Hospitals 81

Hospitals Immunity Immunization 81

FDA Law Blog: Biosimilars

AUGUST 12, 2024

Plaintiffs performed the necessary studies on BRAVECTO and filed an NADA on April 8, 2014; FDA approved the NADA on May 15, 2014. In February 2010, an oral formulation of BRAVECTO, a medication to treat and prevent fleas and tick infestation in dogs, was the subject of an INAD submitted to the Agency.

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59

FDA Law Blog: Biosimilars

MARCH 8, 2023

Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here. Those who use eSubmitter will notice changes in the electronic 3500A template in the first week of March.

Packaging 59

Packaging Communication 59

European Pharmaceutical Review

JULY 4, 2024

4,6 Five patent issues that European biosimilar developers should consider before entering the US market Quality control of the botanical drug substances was one of the critical factors that led to barricades during the development of Veregen and Mytesi. Available from: [link] Apply for a traditional herbal registration (THR) [Internet].

Drug Development 103

Drug Development Documentation Biosimilars Labelling 103

pharmaphorum

FEBRUARY 18, 2021

Eli Lilly’s Humalog compound and formulation patents expired in 2013 and 2014, respectively. In late 2017, the FDA approved Admelog, Sanofi’s biosimilar of Humalog. 6 The stakes were extremely high, with annual costs of insulin reaching $736 per patient in 2013, up threefold since 2002.

Prescription Filling 52

Prescription Filling Drug Pricing Biosimilars Compounding 52

FDA Law Blog: Biosimilars

APRIL 3, 2023

In 2014 Vanda introduced Hetlioz (tasimelteon) capsules to treat a rare sleep disorder. Examples in the regulation include extended-release formulations, new strengths, dosage forms, routes of administration, ingredients, and combinations. See our memo summarizing CMS’s regulation here.

Dosage 59

Dosage 59

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

In September 2014—nearly ten years ago!—PTE But there are still a couple of possibilities lurking out there! The first multiple PTE case up-to-bat concerns Gilead Sciences Inc.’s The first multiple PTE case up-to-bat concerns Gilead Sciences Inc.’s PTE applications were submitted to FDA for each of U.S. RE 44,599 and U.S.

Controlled Substances 59

Controlled Substances Hospitals 59

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

RE 44,599 and RE 44,638 were submitted nearly ten years ago (a point not lost on Gilead as noted below), on September 17, 2014 (Docket Nos.

Documentation 59

Documentation 59

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

2, 2014), [link]. [12] FDA, Transcript of CDRH Webinar regarding Proposed Rule: Medical Devices; Laboratory Developed Tests, at 9-10 (Oct. 31, 2023), [link]. [10] 11] Jeffrey N. Gibbs, Allyson B. Mullen & Melissa Walker, 510(k) Statistical Patterns , MD+DI (Dec. 14] FDA, 510(k) Premarket Notification Search Database (last updated Nov.

Research Laboratories 69

Research Laboratories Documentation 69

Express Pharma

JULY 3, 2023

The Food and Drug Administration (FDA) approved an average of 43 drugs in 2014-18, compared to an average of 23 in the first decade of the century. The biosimilar market in India is estimated to grow at 22 per cent CAGR to become $12 billion by 2025.

Biosimilars 95

Biosimilars Drug Development Generic Medicine Diabetes 95

PharmaTech

JUNE 6, 2025

Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1). This covers new biotechnologically derived protein, glycoprotein, and peptide products as well as biosimilars (3, 4). Biosimilars Market Size | Industry Growth & Forecast Report. Specifications.

Dosage 52

Dosage Drug Development Documentation Biosimilars 52

Express Pharma

OCTOBER 9, 2024

He noted that the number of biotech startups has risen from just 50 in 2014 to over 5,000 now, reflecting India’s increasing focus on bioeconomy. He put forth the importance of Research and Development and regulatory systems, particularly for the deeper work needed in the biologics and biosimilar space.

Vaccines 105

Vaccines Process Improvement Biosimilars Immunity 105

FDA Law Blog: Biosimilars

FEBRUARY 4, 2025

The Tropical Disease PRV program was born the very next year as part of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and expanded in 2014 , which experts heralded as a game-changer for tropical disease therapies.

Vaccines 52

Vaccines 52

FDA Law Blog: Biosimilars

JANUARY 7, 2024

To better understand FDA’s approach in classifying postmarketing pregnancy studies as PMRs or PMCs, we reviewed all postmarketing requirements (PMRs) and postmarketing commitments (PMCs) related to maternal and fetal outcomes in FDA’s PMR/PMC database for drugs approved in the ten-year period from January 2014 through December 2023.

Documentation 59

Documentation Vaccines Drug Development 59

PharmaShots

APRIL 13, 2023

Abbott Laboratories spun off its branded pharmaceutical business into Abbvie Amgen acquired Onyx Pharmaceuticals to boost its portfolio of Immuno-Oncology Johnson & Johnson attained strong growth in 2014 with momentum in their pharmaceutical business and strong sales of their new core products contributing $32.2B to the revenue.

Biosimilars 40

Biosimilars Vaccines Pharmaceutical Companies Pharmaceutical Companies 40

PharmaShots

APRIL 10, 2023

In 2014, FDA approved Afrezza, which is a rapid-acting insulin that is taken before meals Glucagon Administration: In case of hypoglycemia/ low blood sugar, glucagon is administered to diabetes patients Moreover, based on the ability of insulin to infuse into the system, there are six groups or types as depicted in table 1 below.

Diabetes 40

Diabetes Biosimilars Pharmaceutical Companies Pharmaceutical Companies 40

FDA Law Blog: Biosimilars

APRIL 7, 2025

Zoetis and Elanco have previously been the target of CVM complaints about their promotion: Of 10 ULs issued by CVM re advertising since 2014, Zoetis received 4 one in 2025, 2023, 2018 and 2016 and Elanco received 2 ULs 1 in 2018 and another in 2015.

Vaccines 64

Vaccines Adverse Reactions 64

pharmaphorum

DECEMBER 2, 2020

In 2015 the company also paid $17 billion to acquire Hospira , a firm specialising in injectable drugs and biosimilars, at a time when copycat biologics were starting to make real waves in the market. In 2014 the company made an offer of around $100 billion to acquire UK firm AstraZeneca (which at the time was going through a rough patch ).

Compounding 128

Compounding Vaccines Biosimilars Diabetes 128

Big Molecule Watch

MARCH 12, 2025

With 10 years of litigation since the first BPCIA complaint on NEUPOGEN (filgrastim) was filed in 2014, trends are becoming apparent that should cause all biopharma companies to reassess how they protect biologics and plan for biosimilar launch.

Biosimilars 52

Biosimilars Drug Development 52

Big Molecule Watch

DECEMBER 31, 2024

On October 24, 2014, Amgen initiated the first litigation under the Biologics Price Competition and Innovation Act (BPCIA), asserting infringement of two patents. They recognize that larger patent portfolios have proved valuable in delaying biosimilar competition. 262 (l)(5)(A) and (B)(ii). Amgen Inc. , 1, 9, 10, 16 (2017).

Biosimilars 59

Biosimilars 59

RX Note

FEBRUARY 23, 2023

. - Drug registration number Medicines (Advertisement & Sale) Act 1956 and Regulations - To learn prohibitions of medicine advertisement and Medicine Advertisement Board Registration of Pharmacists Act 1951 and Regulations - Pharmacy Board Malaysia and legislation aspects of provisional, full and temporary registration Code of Ethics for Pharmacists (..)

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

FDA Law Blog: Biosimilars

JANUARY 30, 2025

For instance, the December 2024 guidance goes beyond the 2014 Expedited Programs for Serious Conditions Drugs and Biologics guidance (the last to deal substantively with accelerated approval) to describe FDAs expectation that sponsors take a proactive approach to ensuring confirmatory trials are completed within specified timelines.

Drug Development 105

Drug Development Documentation 105

FDA Law Blog: Biosimilars

OCTOBER 14, 2024

2014); U.S. The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. Regenerative Sciences, LLC , 741 F.3d 3d 1314 (D.C. 3d 1302 (11th Cir.

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FDA Law Blog: Biosimilars

MAY 7, 2025

Shoemaker, 746 F.3d 3d 614, 627-28 (5thCir. In Practice Volume-based compensation arrangements for independent contractor sales agents and marketers have long been a concern for HHS OIG.

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59

FDA Law Blog: Biosimilars

MAY 26, 2025

149, 158 (2014). The Supreme Court has recognized the ripeness of pre-enforcement challenges to criminal laws in a number of contexts, including where threatened injury is certainly impending or there is a substantial risk that the harm will occur. Anthony List v. Driehaus , 573 U.S.

Labelling 59

Labelling HIPAA Documentation Immunity 59