BioPharma Drive: Drug Pricing

JULY 22, 2025

Published July 22, 2025 • Updated 2 hours ago Delilah Alvarado Staff Reporter post share post print email license A sign bearing Sanofi's logo sits outside the company's U.S. An antibody drug, Beyfortus , that Sanofi developed with partner AstraZeneca has become a blockbuster product for preventing RSV disease in infants.

Vaccine

The Pharma Data

JUNE 30, 2021

Agreement includes commercializing biosimilar candidate of ophthalmology drug ranibizumab (Lucentis ® ) in Europe, Canada, Israel and global markets. Bioeq has in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilar developer Formycon AG. Source link: [link].

Biosimilars

The Pharma Data

JANUARY 12, 2021

13, 2021 /PRNewswire/ — EVOQ Therapeutics today announced a license and collaboration agreement with Amgen for the discovery and development of novel drugs for autoimmune disorders. EVOQ Therapeutics today announced a license and collaboration agreement with Amgen. ANN ARBOR, Mich. ,

Licensing

Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products.

Biosimilars

FDA Law Blog: Biosimilars

JANUARY 11, 2024

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

Biosimilars

Agency IQ

AUGUST 25, 2023

New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III) commitment.

Biosimilars

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.

Biosimilars

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.” mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g., mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g.,

FDA

FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. Keup has joined the firm to assist attorneys Karla L.

Licensing

FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By way of background, the exclusionary clause was added to the law to protect the pharmaceutical industry against making significant investments in drug development to then be undercut by a dietary supplement marketer who would take the identical product and introduce it as a dietary supplement.

Production

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

As to biosimilars, FDORA amends the statutory language regarding criteria for the demonstration of biosimilarity for a 351(k) biologic. For more on FDORA’s other provisions, see HPM’s complete summary here ). 42 U.S.C. § 262(k)(2)(A)(i)(I). 42 U.S.C. § 262(k)(2)(A)(i)(I). 42 U.S.C. § 262(k)(2)(A)(i)(I). FDORA § 3209(b).

Animal Testing

DrugBank

OCTOBER 4, 2024

These structures are particularly relevant in dealing with uncertainty about the future commercial potential of the target's products. This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams.

Pharmaceuticals

FDA Law Blog: Biosimilars

JUNE 12, 2024

With input from medical professionals, stakeholder, trade associations, and patient advocacy groups, FDA provided a pathway to market for air-conduction hearing aids without a prescription or the involvement of a licensed professional.

FDA

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. In fact, stakeholders have repeatedly challenged FDA’s assertions of authority in Citizen Petitions, public comments, and other forums.

Laboratories

The Pharma Data

OCTOBER 18, 2021

Tofersen binds to SOD1 mRNA, allowing for its declination by RNase-H in an trouble to reduce conflation of SOD1 protein product. under a cooperative development and license agreement. About Tofersen Tofersen is an antisense medicine being estimated for the implicit treatment of SOD1-ALS.

Biosimilars

FDA Law Blog: Biosimilars

JULY 18, 2023

Forty percent of those sites are in what CDER terms the “No Application” sector, meaning that those sites make over the counter (OTC) products, unapproved drugs, and homeopathic products, all sold without premarket approvals. That leaves 60% that manufacture at least one application product.

FDA

The Pharma Data

MAY 2, 2022

Teva Branded Pharmaceutical Products R&D, Inc. NYSE and TASE: TEVA), have reached an agreement with Lupin to resolve the dispute over Lupin’s Abbreviated New Drug Application (“ANDA”) for a generic deutetrabenazine product. and Auspex Pharmaceuticals, Inc., affiliates of Teva Pharmaceutical Industries Ltd.

Pharmaceuticals

FDA Law Blog: Biosimilars

JULY 10, 2025

These particular CRLs were issued in response to original and supplemental drug and biological product applications submitted to the Agency between 2020 and 2024 that ultimately gained approval. 355(l) ) requires that action packages (which include CRLs, if issued) for approved original NDAs and BLAs (i.e.,

FDA

FDA Law Blog: Biosimilars

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.

FDA

FDA Law Blog: Biosimilars

JULY 5, 2023

Under section 503B, drugs compounded by an FDA-registered outsourcing facility under the supervision of a licensed pharmacist can qualify for exemptions from FDA approval, labeling with adequate directions for use, and certain drug supply chain security requirements, subject to specific conditions. Section II at 2. Draft Guidance III.B.2(e)

FDA

FDA Law Blog: Biosimilars

JUNE 17, 2024

Of the 4,819 facilities in the Site Catalog, 60% manufacture drugs approved under a New Drug Application (NDA), Abbreviated NDA (ANDA), or Biologics License Application (BLA). Other notes from the report include: FDA keeps a vast catalog of drug products. That total—148,886 listed products—is a 6% increase over FY2022.

Pharmaceuticals

The Pharma Data

JULY 27, 2021

Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures.

Production

Agency IQ

SEPTEMBER 22, 2023

According to that document, PDURS are “software applications disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products.” patient, caregiver) in the use of their medications (including both pharmaceuticals and biological products) would be considered PDURS.

FDA

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The PTO’s ORDER TO SHOW CAUSE points out that: According to the published Federal Register Notice of July 17, 2020, Lilly requested withdrawal “(revocation)” of its BLA for the human biological product LARTRUVO® (olaratumab).

FDA

The Pharma Data

SEPTEMBER 16, 2020

Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures.

Clinical Trials

The Pharma Data

SEPTEMBER 20, 2020

Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures.

Clinical Trials

The Pharma Data

NOVEMBER 9, 2020

Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures.

Trials

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 (..)

FDA

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.

FDA

The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Refer to the Key Product Revenues schedules for further details. Percent on a Reported Basis, or 12.5

Production

The Pharma Data

JANUARY 24, 2021

On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma. The FTD will significantly accelerate the research, development, and marketing of Toripalimab in the United States.

FDA

Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. FDA, supports concurrent application review for oncology products.

International

Agency IQ

JUNE 29, 2023

As a result, our statutory authority under section 704(a)(4) of the FD&C Act to request records or other information in advance of or in lieu of a drug establishment inspection does not apply to these products.

FDA

The Pharma Data

OCTOBER 29, 2020

Net product sales were $1,588.3 SOLIRIS net product sales were $1,042.3 ULTOMIRIS net product sales were $289.3 ULTOMIRIS net product sales were $289.3 STRENSIQ net product sales were $189.4 KANUMA net product sales were $28.4 ANDEXXA/ONDEXXYA net product sales were $38.9 million , compared to $990.5

Clinical Trials

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

However, this prediction is unfounded, because it assumes that there is an existing classification regulation and/or product code for 90% of currently available LDTs. FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests.

FDA

The Pharma Data

DECEMBER 21, 2020

Secondary endpoints included the effect of tezepelumab on annualized asthma exacerbation rate, lung function, asthma control, quality of life, work productivity and activity impairment. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans.

Trials

The Pharma Data

APRIL 30, 2021

“Our new products are delivering impressive performance and we are on the cusp of potential commercial approvals for more than a dozen new products or indications over the next two years – including five expected approvals in 2021.” percent on an operational basis, due to biosimilar competition.

FDA