FDA Law Blog: Biosimilars

NOVEMBER 27, 2023

17, 2023, the Department of Justice (DOJ) announced the first-ever conviction of two corporate executives in a criminal prosecution for failure to report a consumer product defect under the CPSA. By Riëtte van Laack & Anne K. What led to this conviction? It is a long story that started more than a decade ago.

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The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept. You should not place undue reliance on these statements.

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The Pharma Data

MAY 2, 2021

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept.

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Drug Discovery World

FEBRUARY 22, 2024

Regeneron’s market capitalisation growth was attributed to the FDA approval of its high-dose Eylea – a VEGF fusion protein – for eye diseases, which may likely offset standard Eylea’s expected sales decline following looming biosimilar competition. Bristol-Myers Squibb reported a market capitalisation decline of 31.8%

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Drug Discovery World

MARCH 29, 2023

Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care). Will this be a viable solution? Clinical trials The draft outlines the requirement for clinical trials in children where a drug is approved in adults for a different disease.

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Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. FDORA § 3209(a)(1). FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I). 42 U.S.C. § 42 U.S.C. §

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Vial

APRIL 24, 2024

Introduction In a landscape where many contract research organizations (CROs) are available, Vial is breaking through with its promise to deliver on its vision to empower scientists to cure all human diseases by reimagining clinical trials. Digital therapeutics is not explicitly listed as a therapeutic area of expertise for Syneos Health.

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FDA Law Blog: Biosimilars

AUGUST 23, 2023

DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites. Earlier this year, FDA published the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development (DHT Framework).

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Drug Discovery World

MAY 1, 2023

Key elements of the proposal Better access to medicines New incentives are designed to encourage companies to make their medicines available to patients in all EU countries and develop products that address unmet medical needs. The legislative proposals will now be submitted to the European Parliament and the Council.

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Drug Discovery World

JULY 25, 2023

These guidelines facilitate open communication between regulators and researchers, enabling the industry to adapt and conduct more robust and efficient paediatric clinical studies, while avoiding unnecessary trials. This article will summarise these five guidelines, with a specific focus on modelling and simulation when it is discussed.

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FDA Law Blog: Biosimilars

AUGUST 28, 2023

Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development. While desirable for patients, validation on multiple platforms can lead to challenges.

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FDA Law Blog: Biosimilars

MAY 13, 2024

Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market.” Congress has recognized the challenges with FDA’s acceptance of RWD and RWE.

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Vial

MARCH 1, 2024

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. billion in 2023 attributable to its laboratory products and biopharma services segment (53.8%

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Vial

APRIL 10, 2024

CROs like Vial , IQVIA, PPD, ICON, among others, have distinguished themselves through strategic partnerships and innovative products and services, positioning them as leaders in the industry. It draws upon 150 years of collective experience and expert scientific advisory board members to deeply understand clinical trial requirements.

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The Pharma Data

MARCH 29, 2022

The positive 12- and 52-week results from ELEVATE UC 52 follow the recent announcement of positive 12-week findings from the ELEVATE UC 12 trial on March 23. Etrasimod demonstrated a safety profile consistent with previous studies, including the Phase 2 OASIS trial. About Etrasimod.

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The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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The Pharma Data

DECEMBER 13, 2020

“Zai has a strong track record of rapidly progressing the development of innovative product candidates in China and is well on its way to building its commercial platform. Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. That collaboration was to develop and commercialize four oncology antibody biosimilar therapies.

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The Pharma Data

MARCH 23, 2022

Statistically significant improvements were achieved in all key secondary endpoints in the trial as well. In the study, etrasimod patients achieved statistically significant improvements in the primary endpoint of clinical remission at week 12 as compared with placebo. The safety profile was consistent with previous Phase 2 studies.

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Agency IQ

JANUARY 19, 2024

EMA’s 2023 new medicines report suggests return to pre-pandemic volume This week, the EMA released its 2023 New Medicines Highlights report, providing insights into the number of opinions provided and the types of products reviewed. Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars.

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Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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The Pharma Data

NOVEMBER 10, 2020

that are fast progressing clinical trials. In addition, in order to achieve next level strategic goal of developing global first-in-class product in 5-10 years, Innovent Academy has been established. TYVYT® is the only PD-1 inhibitor included in the NRDL.

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The Pharma Data

MAY 26, 2023

Abstracts include new data from pivotal trials supporting ongoing regulatory reviews for three potential therapies, if approved, and new clinical data for six early pipeline assets. Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development.

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Drug Discovery World

OCTOBER 20, 2022

Many of the top-selling pharmaceuticals are biopharmaceuticals; however, the products account for approximately 15% of overall sales in Japan, which is significantly lower than the global biopharmaceutical sales ratio of approximately 30%. Similarly, biosimilars are expected to grow. Eisai and Biogen’s anti-amyloid beta (A?)

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Conversations in Drug Development Trends

JULY 9, 2024

The demand for these medications, which play a vital role in managing diabetes and obesity, has far outpaced production capabilities, leading to widespread scarcity. Ethical Considerations During clinical trials, participants are either already on a stable, maintenance dose or are provided with the GLP-1 medication for the study’s duration.

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Agency IQ

MARCH 1, 2024

The EMA has a number of scientific guidelines and reflection papers that are currently open for public consultation, including the development of products for the treatment of depression, Hepatitis B, and hemophilia A and B.

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Agency IQ

AUGUST 2, 2024

Title Type Date Received by OIRA Legal Deadline Expedited Program for Serious Conditions –Accelerated Approval of Drugs and Biologics Draft Guidance July 9 Yes Conducting Clinical Trials With Decentralized Elements Draft Guidance July 25 Yes Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Draft (..)

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Agency IQ

DECEMBER 1, 2023

Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U. Positive January 2023 Azacitidine Kabi (azacitidine)** Fresenius Kabi Deutschland GmbH Positive January 2023 Krazati (adagrasib) Mirati Therapeutics B.V.

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Agency IQ

AUGUST 2, 2024

While the work on the pharma package will likely take quite some time, another deadline is coming up fast: the full transition of all clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation. Product management services are expected to go-live soon with the activation of the input portals.

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Agency IQ

JULY 13, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUL 10, 2023 10:02 AM CDT As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products).

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The Pharma Data

MAY 6, 2021

ENVI calls on the Commission to “revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU.”. . Denmark posts guidance on decentralizing clinical trials.

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FDA Law Blog: Biosimilars

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

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The Pharma Data

MAY 18, 2021

Kundl, Austria further strengthens production for oral antibiotics while facility in Palafolls, Spain expands for sterile active pharmaceutical ingredients. As part of this network modernization plan, Sandoz will phase out the current production of oral APIs at the Les Franqueses site in Spain, which it plans to close in 2024.

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Agency IQ

MARCH 29, 2024

Andrews, Oxford, the British Medical Journal Medicine products pending European Commission decision following CHMP opinion Below are the drug or biologic products for which decisions are expected to occur within the next two months, according to AgencyIQ’s review of opinions from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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The Pharma Data

OCTOBER 26, 2021

Q3 core¹ operating income grew +9% (cc, +10% USD) Innovative Medicines grew +13% (cc, +14% USD), due to higher sales and productivity programs Sandoz declined -15% (cc, -13% USD), impacted by gross margin Q3 operating income grew +32% (cc, +34% USD) Q3 net income increased +41% (cc, +43% USD) Q3 free cash flow 1 of USD 4.4

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Agency IQ

JULY 8, 2024

FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

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