Pharmaceutical Technology

NOVEMBER 30, 2022

Biocon subsidiary Biocon Biologics has acquired the international biosimilars business of Viatris in a deal totalling $3bn. The post Biocon Biologics acquires biosimilars business of Viatris for $3bn appeared first on Pharmaceutical Technology. This therapy is intended for the treatment of various ophthalmology conditions.

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Biosimilars 52

Express Pharma

NOVEMBER 8, 2023

Biocon Biologics has entered into a definitive agreement with Eris Lifesciences (Eris) for the divesture of its dermatology and nephrology branded formulations business units in India that mostly comprised of its legacy small molecules’ brands.

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Biosimilars 105

Safe Biologics

DECEMBER 8, 2022

ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP gave a presentation entitled “Key Factors for Improving Sustainability in Biosimilar Markets”. Among the factors identified in the webinar were the ability for physicians to choose freely between multiple products- innovators and biosimilars- when prescribing.

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Biosimilars Communication Drug Development 100

FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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Biosimilars Labelling Communication 59

European Pharmaceutical Review

NOVEMBER 9, 2023

In this issue, Peter Stenico, Biosimilar Global Platform Head at Sandoz, highlights how emerging technology platforms such as nanobodies, ADCs and cell and gene therapies are “on course to revolutionise medicine,” with significant growth anticipated over the next decade.

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Biosimilars Drug Development 98

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R. Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.”

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Biosimilars Dosage 59

Big Molecule Watch

DECEMBER 28, 2023

Below is a recap of the top M&A deals in 2023 that focus on biologics and biosimilars and were covered on the Big Molecule Watch. Reddy’s”) to license Dr. Reddy’s proposed biosimilar abatacept for the development and commercialization of COYA 302 for the treatment of neurodegenerative conditions. Reddy’s Laboratories Ltd. (“Dr.

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Biosimilars Labelling 69

FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

Overall, the final guidance provides many editorial clarifications as well as some noteworthy updates, including discussions on DHTs that meet the definition of a device, selection of a DHT and rationale for use in a clinical investigation, retention and protection of data collected by DHTs, and DHT updates.

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Documentation 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.

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Biosimilars Labelling Documentation 98

FDA Law Blog: Biosimilars

JULY 11, 2023

To set the stage for this case, we need to go back to March 2020 , when a new definition of “biological product” threw the world of protein products into a tizzy. As a result of the Biologics Price Competition and Innovation Act (BPCIA) passed in 2010, the definition of a “biological product” expanded to include “proteins.”

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FDA Law Blog: Biosimilars

APRIL 25, 2023

510(k), premarket approval application (PMA), Product Development Protocol (PDP), De Novo, or Humanitarian Device Exemption (HDE)] for a device that meets the definition of a cyber device under this section shall include such information as [FDA] may require to ensure that such cyber device meets the cybersecurity requirements. . . .

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Documentation Labelling Communication 105

Big Molecule Watch

JUNE 22, 2023

announced that they have entered into a definitive merger agreement, where, at the closing, Coherus will acquire Surface Oncology, a clinical-stage immuno-oncology (I-O) company developing next-generation immunotherapies that target the tumor microenvironment. On June 16, 2023, Coherus BioSciences, Inc. and Surface Oncology, Inc.

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Biosimilars 56

European Pharmaceutical Review

FEBRUARY 23, 2023

There is no definitive answer as to whether life sciences companies should, or should not, opt their EPs out of the UPC. Arrow declarations are useful for generics or biosimilars as they give commercial certainty that a product may be launched without the risk of a later infringement action. Patents: a necessary evil?

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Biosimilars Compounding 98

Pharma in Brief

FEBRUARY 8, 2024

On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product ( CRP ) in the Food and Drug Regulations ( Regulations ). By contrast, biosimilar drugs must be approved through a New Drug Submission.

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Biosimilars 52

FDA Law Blog: Biosimilars

JUNE 13, 2024

Though the Court acknowledged that the definition of the term “drug” is broad enough to include the ProAir HFA inhaler, the Court found that “this broad statutory definition of drug does not suffice to establish the Inhaler Patents claim the drug for which Teva submitted its application.”

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Dosage 116

FDA Law Blog: Biosimilars

MAY 6, 2024

FDA interprets the “software” definition to include software that is firmware or programmable logic in addition to software in a medical device (SiMD) or software as a medical device (SaMD). For medical devices that meet the definition of a cyber device, manufacturers are required to submit specific information in premarket submissions.

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Documentation 105

FDA Law Blog: Biosimilars

AUGUST 4, 2023

DASCA amended the CSA by revising and adding specified substances to the definition of “anabolic steroid,” providing for the temporary and permanent scheduling of anabolic steroids and adding labeling requirements for products containing anabolic steroids. Implementation of the Designer Anabolic Steroid Control Act of 2014 , 88 Fed.

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Controlled Substances Labelling 52

Pharmaceutical Technology

JUNE 19, 2023

Coherus BioSciences has signed a definitive merger agreement to buy clinical-stage immuno-oncology (I-O) company Surface Oncology, in a deal valued at $65m. The company will buy all outstanding Surface Oncology shares at a price of $5.2831 per share, totalling approximately $40m, along with anticipated net cash of between $20 and $25m.

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Biosimilars Immunity Immunization 52

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. FDA further retained some definitions in the QSMR. FDA further retained some definitions in the QSMR. Certain definitions are also removed from § 820.3, Revised § 820.3

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Labelling Packaging Documentation 59

Drug Channels

FEBRUARY 21, 2023

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. The 2023 Economic Report on U.S.

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Specialty Pharmacies Drug Pricing Biosimilars 97

FDA Law Blog: Biosimilars

JULY 23, 2024

Drug delivery includes successful product preparation and the initiation, progression, and completion of dose delivery.

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Labelling 105

Big Molecule Watch

MARCH 1, 2024

As background: the IRA defines “qualifying single source drugs” as drugs that are, among other things, (a) approved or licensed under the NDA or BLA provisions of the FDCA or BPCIA and (b) not the reference product for any generic or biosimilar that is “approved and marketed” (or “licensed and marketed”) pursuant to an ANDA or aBLA.

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Biosimilars Drug Pricing Dosage Documentation 59

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

Here, the draft guidance states that the appropriate timing for an INTERACT meeting should be when a sponsor has identified a specific product and has conducted some preliminary proof-of-concept (POC) studies but has not yet designed and conducted definitive toxicology studies.

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Documentation Packaging Clinical Pharmacology Drug Development 59

European Pharmaceutical Review

JULY 4, 2024

It begs the question of why only two botanical drug products have obtained FDA approval and fulfilled the Botanical Guidance definition of a botanical product. 2 In addition, the nature of botanical products adds another layer of complexity in terms of obtaining FDA approval.

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Drug Development Documentation Biosimilars Labelling 103

Big Molecule Watch

AUGUST 25, 2023

With the IRA, Congress changed the pricing model for certain “high-priced” Medicare-covered drugs without generic or biosimilar competition. Drugs are considered to be “qualifying single-source drugs” if they have been without generic or biosimilar competition for a certain number of years.

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Drug Pricing Biosimilars Insurance Coverage and Processing Labelling 40

Pharma in Brief

NOVEMBER 5, 2023

For a generic or biosimilar product, the manufacturer may also apply to have the drug product designated on the Formulary as interchangeable with the original brand product. The government is seeking feedback on the proposed amendments. Requirements for obtaining a listing are set out in O.

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Dosage Biosimilars 52

FDA Law Blog: Biosimilars

MAY 19, 2024

Speakers at the Scientific Workshop will include Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research, Dr. Janet Woodcock, former Principal Deputy Commissioner of the FDA, Dr.

Drug Development 59

Drug Development 59

FDA Law Blog: Biosimilars

OCTOBER 9, 2023

As applied to manufacturer assistance, CMS did not adopt a single interpretation of the statutory or regulatory definition of “cost sharing.” The Court specifically concluded that the rule “rests on two contradictory interpretations of the statute” and “conflict[s] with the regulatory definition.”

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FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

Upon receipt of the 513(g), FDA will assess whether the product meets the definition of a device under section 201(h) of the FD&C Act. If it does, the letter will also identify the device class, whether a premarket notification or premarket approval is required to market the device, and other pertinent information.

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Documentation Labelling 69

Putting Patients First Blog

DECEMBER 9, 2024

Biosimilars and Generics The formulary inclusion of biosimilars and generics is essential in reducing the costs of medications for Medicare recipients. To enable lower cost medications, CMS would require that plan formularies prioritize access to biosimilars, generics, and affordable other alternatives.

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Medication Therapy Management (MTM) Biosimilars Inpatient Communication 52

FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. On August 28 of this year, NPA sued FDA challenging FDA’s determination that NMN is excluded from the dietary supplement definition.

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Drug Development 59

FDA Law Blog: Biosimilars

SEPTEMBER 25, 2024

From Chapter 1 (My First Generic Drug Client), through Chapter 4 (The Hatch-Waxman Act), to Chapter 12 (My Prescription for the Future), the 208-page “Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer” is definitely worth a read!

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PharmaShots

MAY 26, 2023

Takeda and HUTCHMED's Fruquintinib Receives Priority Review from the US FDA to Treat Metastatic Colorectal Cancer Date: May 26, 2023 | Tags: Takeda, HUTCHMED, Fruquintinib, Metastatic Colorectal Cancer, Regulatory, Priority Review, US, FDA Gilead Receives EMA’s CHMP Positive Opinion to Extend the Use of Veklury (remdesivir) for COVID-19 Date: (..)

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Biosimilars 40

FDA Law Blog: Biosimilars

APRIL 10, 2023

Houck — Drugs and substances classified within schedule I of the federal Controlled Substances Act (“CSA”) by definition have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision. By Larry K. 21 U.S.C. § 802(a) (7)(A)).

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Controlled Substances 59

FDA Law Blog: Biosimilars

MAY 15, 2023

A major component of AAFCO is its work on ingredient definitions, specifying what ingredients may be use in animal feed under what conditions. AAFCO’s ingredient definitions are not federal regulations and do not have the force or effect of federal law. The goal is to create uniformity to facilitate interstate commerce.

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Labelling Documentation 45

FDA Law Blog: Biosimilars

AUGUST 14, 2024

Among other topics, the memorandum summarizes CMS’s proposed regulations for both these Part B and Part D inflation rebate programs, including: Key definitions; The drugs to which the rebates apply; Methods of calculating and applying rebates; Processes for reporting, reconciling, and paying rebates; and Penalties and enforcement.

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Pharmaceutical Manufacturing Drug Pricing 59

PharmaShots

FEBRUARY 3, 2023

4D Molecular Therapeutics Receives the US FDA’s IND Clearance of 4D-150 for the Treatment of Diabetic Macular Edema Date: Feb 03, 2023 | Tags: 4D Molecular Therapeutics, 4D-150, Diabetic Macular Edema, Regulatory, US, FDA, IND AstraZeneca and Amgen Receive the US FDA’s Approval of Tezspire (tezepelumab) for the Treatment of Severe Asthma (..)

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Biosimilars Diabetes Labelling 40