European Pharmaceutical Review

JULY 4, 2024

2 It was first approved as Fulyzaq in December 2012 and in October 2016, Napo Pharmaceuticals launched the new brand, Mytesi. 14 Marketing authorisation In the UK, medicinal products placed on the market are required to have marketing authorisations in accordance with The Human Medicines Regulations 2012 (S.I. 2012/1916).

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Drug Development Biosimilars Documentation Labelling 103

FDA Law Blog: Biosimilars

NOVEMBER 27, 2023

According to the government, these companies knew as early as 2012 that their dehumidifiers were defective, in that they could overheat and catch fire. (the “Gree Companies”), an appliance manufacturer and two of its subsidiaries that were involved in the manufacturing, marketing, and sale of dehumidifiers.

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FDA Law Blog: Biosimilars

MAY 13, 2024

Based on a review of premarket submissions made in 2012 through 2019, FDA identified 90 examples of 510(k)s, De Novos, HDEs, and PMAs approved/cleared which utilized RWE in support of regulatory decision-making. During this period the estimated total number of such submissions was approximately 26,121.

Medical Records 111

Medical Records Documentation 111

pharmaphorum

SEPTEMBER 29, 2020

Junshi was founded in 2012 and since then has built a pipeline comprising of 26 innovative drugs and two biosimilars, covering five therapeutic areas – cancer, autoimmune, metabolic, neurologic, and infectious diseases. It has also been granted orphan drug designation by the FDA for mucosal melanoma.

Chemotherapy 40

Chemotherapy Biosimilars 40

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

12, 2012). “[W]hen the circumstances surrounding the presentation of a prescription would give rise to suspicion in a ‘reasonable professional,’ there is a duty to question the prescription.” Holiday CVS, L.L.C. d/b/a CVS/Pharmacy, Nos. 219 and 5195; Decision and Order , 77 Fed. 62,316, 62,342 (Oct.

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Controlled Substances Documentation Dosage Prescription Filling 139

FDA Law Blog: Biosimilars

AUGUST 10, 2023

Section 704(a)(4) was added to the FDCA by the Food and Drug Administration Safety and Innovation Action (FDASIA) in July 2012. Despite FDA having the authority to conduct paper inspections since the statutory provision was added to the FDCA by FDASIA in 2012, FDA did not issue a warning letter citing Section 704(a)(4) until January 2021.

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Compounding 52

PharmaShots

MARCH 29, 2023

Some companies accept the offered period and open doors to biological drugs or biosimilars. Company: Takeda Generic Name: Teduglutide First Approval Date: Dec 21, 2012 Patent Expiration: Mar 2023 2022 Sales: $540M Indication: Short Bowel Syndrome (SBS) Gattex is a subcutaneous injection used in SBS patients dependent on parenteral support.

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Biosimilars Diabetes Chemotherapy Immunization 49

FDA Law Blog: Biosimilars

MARCH 13, 2023

The FDA took an early lead in the evolution of this movement when they launched the Patient Focused Drug Development (PFDD) initiative in 2012. Rather than speaking with one or two people with a condition of interest as had been previously done, they sought to find a more systematic way of getting broad patient and caregiver feedback.

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Pharmaceutical Technology

NOVEMBER 14, 2022

Almac is involved in manufacturing 35 known drugs (innovator and/or biosimilar) that are marketed in the US, according to GlobalData’s Drugs by Manufacturer database. Other UK-based international manufacturing players include companies like Abzena Ltd (Cambridge, UK), AstraZeneca (Cambridge, UK), and Almac Group Ltd (Craigavon, UK).

Packaging 59

Packaging Biosimilars 59

FDA Law Blog: Biosimilars

APRIL 16, 2024

It creates the prospect of larger inflation-based rebates, which make up an increasingly large portion of the total amount paid under the Medicaid Drug Rebate Program—more than half since 2012.”

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Dosage Drug Pricing Pharmaceutical Manufacturing 59

FDA Law Blog: Biosimilars

APRIL 30, 2023

112-144 (2012). 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. 110-85 (2007), as amended by Section 301 of Pub.

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Immunization Immunity Biosimilars Labelling 59

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.

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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).

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Biosimilars Immunization Immunity Drug Development 98

FDA Law Blog: Biosimilars

AUGUST 18, 2024

In 2012, the FDCA was modified to allow the submission of a De Novo request without the need for a prior 510(k), and set a target review time by FDA of 120 days. This amendment allowed sponsors with low or moderate risk devices to proactively employ the De Novo process.

Hospitals 69

Hospitals Documentation 69

FDA Law Blog: Biosimilars

APRIL 3, 2023

This objection echoed a criticism that had been expressed by industry ever since CMS’s proposed rule in 2012. Finally, the court finally addressed Vanda’s claim that CMS’s definition of line extension was overly broad, exceeding Congress’ intent to capture only slight alterations to existing drugs.

Dosage 59

Dosage 59

Express Pharma

AUGUST 13, 2024

billion green loan to fund its purchase of Viatris’ biosimilars business. Our admin building, at Goa site, is Green Building certified by IGBC with LEEDS Platinum rating since 2012 and our commitment to sustainability extends to the automation of our logistics with the implementation of a robotic warehouse ASRS.

Pharmaceutical Manufacturing 64

Pharmaceutical Manufacturing Packaging Biosimilars Pharmaceutical Companies 64

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

Our fourth example ties in our Part 1 post and the references to BELVIQ (lorcaserin HCl) Tablets (NDA 022529; approved on June 27, 2012) and the Improving Regulatory Transparency for New Medical Therapies Act (“IRTNMTA”), with the PTO’s December 21, 2023 ORDER TO SHOW CAUSE “based on the apparent ineligibility of U.S.

Documentation 59

Documentation 59

PharmaShots

APRIL 13, 2023

Johnson & Johnson delivered solid results in 2012 with profitable growth due to their top and newly developed products that lead to a revenue of $67.2B. The company faced a tough time in 2019 as the first biosimilars for its best-selling drugs (Rituxan, Avastin, and Herceptin) emerged.

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Biosimilars Vaccines Pharmaceutical Companies Pharmaceutical Companies 40

FDA Law Blog: Biosimilars

MARCH 4, 2024

Since the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, manufacturers have been required to notify FDA of product changes affecting certain finished drugs and biological products.

Communication 59

Communication 59

Pharmaceutical Technology

JULY 23, 2008

” 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. “Intellectual property is becoming more of an issue,” says Ando.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Compounding Biosimilars 40

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 (..)

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Controlled Substances Hospitals 59

Safe Biologics

MAY 10, 2024

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. and Europe alike, prescribers can already substitute any biosimilar for its reference product. Currently there are 10 biosimilars that can be substituted by U.S.

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Biosimilars Drug Pricing Documentation Labelling 130

FDA Law Blog: Biosimilars

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

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Inpatient Hospitals Dosage Controlled Substances 59

FDA Law Blog: Biosimilars

DECEMBER 1, 2024

Then along came the FDA Safety and Innovation Act (“FDASIA”) (our firm’s summary of the law, which was enacted in 2012, is here ). FDASIA authorized FDA, in Section 707(b), to issue a guidance about what constitutes refusing an authorized FDA inspection, which is a crime under Section 301(f) (21 U.S.C. 331(f)).

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Documentation Labelling 113

FDA Law Blog: Biosimilars

JANUARY 9, 2025

Although FDA has long taken the position that it has broad authority in how it conducts its inspections, it was not until 2012 that Congress put some teeth behind FDAs policy position. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection.

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Documentation Labelling 105

European Pharmaceutical Review

DECEMBER 23, 2024

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA. November 2012. September 1999, CPMP/ICH/365/96. Eglovitch JS. EU Official Says ICH Q6B Is Outdated And Needs Revision. Internet] Regulatory Focus. cited 2024August]. Available from: [link] 4. Pharmaceutics. 2021; 13(1): 48. 22 June 2017. 4 March 2020.

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Biosimilars Vaccines 52

pharmaphorum

FEBRUARY 5, 2021

But that was in 2012 and although the FDA has taken several steps to tighten regulation on opioids, they remain on the market with addiction still a major problem in the US. The FDA did go on to add warning labels in the following years and eventually decided to require a class-wide monitoring programme, with training for doctors.

Vaccines 119

Vaccines Biosimilars Labelling 119

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).

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