Big Molecule Watch

OCTOBER 11, 2023

FDA grants interchangeable designation to Pfizer’s adaliumumab biosimilar – On October 5, 2023, Pfizer Inc. Food and Drug Administration (FDA) has designated ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to HUMIRA (adalimumab). The post Recent Adalimumab Biosimilar Developments appeared first on Big Molecule Watch.

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Biosimilars 64

Pharmaceutical Technology

MAY 19, 2023

Rituxan’s success made it a prime target for biosimilar developers. Globally, the first rituximab biosimilar, Dr Reddy’s Laboratories’ Reditux, was approved in India in 2007. The first approved biosimilar in the US and EU was Celltrion/Teva Pharmaceutical’s Truxima/Blitzima in 2018 and 2017, respectively.

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Biosimilars 59

FDA Law Blog: Biosimilars

APRIL 8, 2025

The DCAP was an initiative launched in 2017 to remove barriers to generic drug development, approval, and market entry (see our previous post here ). About one third of these PSGs are for complex products and many reflect what OGD and DPD learned about the science of equivalence from GDUFA-funded regulatory science research.

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Documentation Labelling Drug Development 142

Drug Patent Watch

DECEMBER 26, 2024

Encourage Competition : Policies should be implemented to encourage the entry of additional domestic and international providers of generics and biosimilars, particularly including those not marketed by the original patent holder. Conclusion In conclusion, generic drugs play a vital role in making medicines more affordable for patients.

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Drug Pricing Biosimilars 98

Big Molecule Watch

JUNE 30, 2023

Beginning tomorrow, July 1, 2023, CYLTEZO® (adalimumab-adbm) will become the first HUMIRA® (adalimumab) biosimilar with interchangeable status to be commercially available in the United States. In addition to CYLTEZO, the FDA has approved eight additional adalimumab biosimilars over the last six years.

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Biosimilars 64

Safe Biologics

FEBRUARY 1, 2024

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability. Comments may be submitted here until April 30, 2024.

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Biosimilars Documentation Drug Pricing 130

Big Molecule Watch

DECEMBER 14, 2023

announced that the FDA has approved AVZIVI (bevacizumab-tnjn), a biosimilar referencing Genentech’s AVASTIN. Bio-Thera previously received approval for its TOFIDENCE (tocilizumab-bavi) biosimilar in September 2023. The post Recent Biosimilar Approvals appeared first on Big Molecule Watch.

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Biosimilars Diabetes 45

Safe Biologics

JANUARY 1, 2023

ASBM Adds Module on PBM Practices to OSU College of Pharmacy Biosimilars Course In December, ASBM recorded the seventh and final module in its biosimilar Continuing Education (CE) Course on Biosimilars, presented with the Ohio State University College of Pharmacy. Feldman explains unique features of the U.S. The bifurcated U.S.

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Biosimilars Drug Pricing 100

pharmaphorum

DECEMBER 21, 2020

Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.

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Biosimilars Chemotherapy Immunity Immunization 126

Big Molecule Watch

MAY 20, 2024

Earlier this month, FDA approved Boehringer Ingelheim’s high-concentration (100 mg/mL), citrate-free formulation, CYLTEZO (adalimumab-adbm), a biosimilar to Humira (adalimumab). CYLTEZO was first approved in the US in 2017 and later approved in the US as an interchangeable biosimilar to Humira in October 2021.

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Biosimilars Labelling 45

pharmaphorum

OCTOBER 19, 2021

Biosimilar competition to AbbVie’s big-selling Humira drug in the US has just been ratcheted up by the FDA approval of Boehringer Ingelheim’s Cyltezo – which can be substituted for the reference drug without any prescriber intervention. The post FDA clears first “interchangeable” Humira biosimilar appeared first on.

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Biosimilars Labelling 40

Big Molecule Watch

MAY 23, 2023

According to a previous announcement from Boehringer Ingelheim, Cyltezo is an FDA-approved Interchangeable biosimilar to Humira (adalimumab) and its commercial license will begin on July 1, 2023. On May 22, 2023, Boehringer Ingelheim announced that the FDA has approved the Cyltezo Pen, a new autoinjector option for Cyltezo (adalimumab-adbm).

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Biosimilars 72

Big Molecule Watch

NOVEMBER 21, 2023

District Court for the District of New Jersey, alleging infringement of 15 patents under the BPCIA based on DRL’s submission of an aBLA for DRL_RI, a proposed biosimilar of RITUXAN (rituximab) and DRL’s provision of Notice of Commercial Marketing with respect to the same. Stay tuned to Big Molecule Watch for more updates on this litigation.

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Biosimilars Labelling 49

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.

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Biosimilars 119

Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. For example: Reduced stay. Revised section 8 damages.

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Biosimilars Dosage Documentation 52

FDA Law Blog: Biosimilars

MAY 13, 2024

It was Congress that intervened in 2022, to mandate FDA to issue or revise its 2017 guidance on considerations for the use of RWD and RWE to support regulatory decision-making for devices to clarify its regulatory expectations. This guidance, when finalized, will replace the original version of this document finalized in 2017.

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Medical Records Documentation 111

Pharmaceutical Technology

SEPTEMBER 15, 2022

Upcoming biosimilar competition for Humira means AbbVie’s focus may turn to Rinvoq, approved in the US for atopic dermatitis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis, and Skyrizi, approved in the US for psoriatic arthritis and plaque psoriasis. AbbVie reported a 22.7%

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Vaccines Drug Pricing Biosimilars Documentation 108

Big Molecule Watch

APRIL 12, 2023

In 2017, three indirect-purchaser antitrust class actions were filed against Johnson & Johnson and Janssen Biotech, Inc., alleging that they engaged in anticompetitive conduct relating to the sale and marketing of J&J’s REMICADE (infliximab). 200, and the Local 295 IBT Employer Group Welfare Fund.

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Biosimilars 72

pharmaphorum

JULY 4, 2022

At Teva , he replaces Hafrun Fridriksdottir, a 25-year Teva veteran who was named R&D chief almost immediately after Kare Schultz took over the reins of Teva in 2017 with the task of turning around the fortunes of the ailing generics giant. He will be based out of Teva’s US headquarters in Parsippany, New Jersey.

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Generic Medicine Biosimilars 52

FDA Law Blog: Biosimilars

JULY 31, 2023

With the amendment by CARA, the CSA allows for partial dispensing of schedule II prescriptions if not prohibited by state law, is requested by the patient or prescriber and the total quantity dispensed in partial fillings does not exceed the total quantity prescribed. 21 U.S.C. §

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Controlled Substances Long-Term Care Facilities Dosage Communication 98

pharmaphorum

FEBRUARY 18, 2021

In late 2017, the FDA approved Admelog, Sanofi’s biosimilar of Humalog. Since losing exclusive rights in 2017, Pfizer undertook an over-the-counter switching strategy to guard against revenue loss. In 2017, Pfizer announced it would produce a generic version, called Sildenafil, at half the cost of the brand name.

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Prescription Filling Drug Pricing Biosimilars Compounding 52

FDA Law Blog: Biosimilars

MAY 27, 2024

Jennifer was with the firm from 2011-2017, before leaving for in-house roles at Apple, Abbott Laboratories, and Cognito Therapeutics. “Jennifer’s return adds depth and breadth to our device practice and her strong relationships from her earlier time at the firm has made for a seamless reentry,” said J.P. Ellison, Managing Director at HPM.

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European Pharmaceutical Review

NOVEMBER 7, 2023

Five patent issues that European biosimilar developers should consider before entering the US market In the second proposed Regulation the Commission has set out legislation for a unitary SPC. The first proposed Regulation focuses on the prosecution procedure for SPCs in the EU. References 1. EPO unitary patent dashboard. Cited 2023Sept].

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Biosimilars 105

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] Herbal medicinal products: scientific guidelines. cited 2024May].

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Drug Development Biosimilars Documentation Compounding 103

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Prescribing Red Flags The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.” If the pharmacist can resolve it, they must make a record of the resolution. Complaint ¶ 55.

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Controlled Substances Documentation Dosage Prescription Filling 139

FDA Law Blog: Biosimilars

SEPTEMBER 27, 2023

Tobolowsky — Much has changed since the long-gone days of 2017. While the Nats being replaced by the Orioles as the dominant home team did not get a mention in the new Draft Guidance, there were plenty of other interesting changes made to the old 2017 draft guidance. By James E. Valentine & Mark A. Now, we know better.

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Packaging Drug Development Documentation 64

FDA Law Blog: Biosimilars

SEPTEMBER 28, 2023

Richard Marschall, a “naturopathic doctor,” had been convicted in 2017 for a misdemeanor violation of the FDC Act for selling misbranded drugs. While Marschall was convicted of a felony based on one earlier 2017 FDC Act conviction, in a footnote, the 9th Circuit notes that this was actually Marschall’s third FDC Act conviction.

Labelling 52

Labelling 52

FDA Law Blog: Biosimilars

JUNE 28, 2023

In accordance with amendments made to section 514 by the FDA Reauthorization Act of 2017 (FDARA), and as part of the enactment of the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA was directed to issue guidance regarding the goals and implementation of the ASCA Pilot.

Documentation 52

Documentation 52

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 (..)

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Hospitals Immunization Immunity 81

FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

Regarding CDER’s ETP, the current ETP guidance document, originally published in 2017, will be updated by the end of 2026, and will include details on communicating the type of products and stages of development for which a requestor can approach the ETP.

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Documentation Communication 59

FDA Law Blog: Biosimilars

MARCH 29, 2024

GAO reports that BIMO inspections peaked in 2017 when FDA was able to complete over 970 visits. These are BIMO inspections of hospitals, clinical research organizations (CROs), and other similar facilities where clinical trial work is performed. The vast majority are for drugs.

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Hospitals 59

PharmaShots

APRIL 26, 2023

mL Mechanism of Action: interleukin-4 (IL-4) and interleukin-13 (IL-13) inhibitor First Approvals: FDA (Mar 28, 2017), EC (Sep 27, 2017), NMPA (Jun 19, 2020), MHLW (Jan 22, 2018) Originator: Sanofi & Regeneron Revenue Analysis1 Dupixent is developed and commercialized in collaboration with Regeneron. mL, 100 mg/0.67

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Biosimilars Dosage 56

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. What does- and does not- drive Biopharma cost performance The Boston Consulting Group (2017) [Accessed 14 October 2020] 8. International Aspirin Foundation. Bressau, P.

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Biosimilars Dosage Pharmaceutical Companies Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

15, 2017), [link]. [18] 22] FDA, Financial Report to Congress: Medical Device User Fee Amendments of 2017 FY 2022, at 27, [link]. [23] 15, 2017), [link]. [18] 22] FDA, Financial Report to Congress: Medical Device User Fee Amendments of 2017 FY 2022, at 27, [link]. [23] 360(m)(a)(3). [16] 31, 2023), [link]. [17]

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Research Laboratories Documentation 69

FDA Law Blog: Biosimilars

JUNE 17, 2024

OPQ reports that the vast majority of the 81 drug shortages reported in CY2022-23 were due to quality issues (40%) and increase in demand (40%)—a significant change from 2013-2017 when quality issues were the cause of 62% of shortages.

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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

PharmaState Academy

MAY 1, 2023

In the coming age of biopharmaceuticals and biosimilars, every patient will have different needs, especially young patients with life-style disease problems. a pharmaco strong in biopharmaceuticals or biosimilars can work closely with banks. Some may need more education on self-care and home-care.

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Department of Veterans Affairs Communication Hospitals Biosimilars 52