Med Ed 101

OCTOBER 24, 2021

FDA-approved biosimilars have been compared to a biologic and shown to be highly similar in structure and function. At the time this article was written, there are currently 31 FDA-approved biosimilars. The “Purple Book” can be found on the FDA website […]. The “Purple Book” can be found on the FDA website […].

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Biosimilars 40

pharmaphorum

SEPTEMBER 20, 2022

Novartis’ soon-to-be-divested Sandoz unit has positive clinical trial data in hand for a biosimilar of Amgen’s blockbuster osteoporosis therapy Prolia (denosumab), clearing the way for regulatory filings. Other companies working on biosimilar versions of denosumab include Samsung Bioepis, Celltrion, and AryoGen Pharmed.

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Biosimilars 52

FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Last week, the FTC held a Listening Session about the listing of patents in the Orange Book, which concluded with a unanimous vote to issue a Policy Statement.

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Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “NEXSYMEO.”

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Labelling Biosimilars Adverse Reactions Dosage 49

FDA Law Blog: Biosimilars

SEPTEMBER 25, 2024

Throughout his illustrious career, Al has been engaged with Hatch-Waxman, even authoring one of the earliest papers providing an account of the law: “ Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness? ” In his new book, “Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer,” which will be released (..)

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Big Molecule Watch

JANUARY 16, 2024

(collectively “J&J”) in the Eastern District of Virginia alleging that J&J “is unlawfully delaying the introduction of biosimilar competition for ustekinumab.” The are currently six patents listed in the Purple Book for J&J’s STELARA (ustekinumab). The plaintiffs are represented by Glasser and Glasser, P.L.C.,

Biosimilars 64

Biosimilars 64

pharmaphorum

DECEMBER 13, 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 111

pharmaphorum

AUGUST 23, 2021

Novartis and Roche’s big-selling eye drug Lucentis has its first biosimilar competitor in Europe, after the European Commission approved Samsung Bioepis’ copycat drug Byooviz. Sales reached a peak in 2019, when Roche booked $1.8 billion in sales from the drug while Novartis made $2.1 billion for Roche and $1.9

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Biosimilars Diabetes 40

PharmaShots

FEBRUARY 2, 2023

The agreement is a multi-product and multi-year deal to develop products and license IP for four biosimilar assets targeting indications in oncology, inflammation, and blood disorders. Smriti: Give our readers details about the four biosimilar products to be developed and licensed by Blau.

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Biosimilars 40

pharmaphorum

OCTOBER 24, 2021

Cheaper biosimilar versions of Lucentis from Samsung Bioepis/Biogen, Hospira and Formycon/Bioeq are however due to enter the US market shortly. Last year, Roche booked around $1.5 Roche and Novartis share rights to Lucentis, with Roche selling the drug in the US and Novartis selling it in Europe and other markets.

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Biosimilars 98

FDA Law Blog: Biosimilars

MARCH 12, 2025

Raimondo Exploring the On-Sale Bar and Applicability of Prior Art Orange Book Delisting Attempts Navigating ODP and Patent Family Dynamics Hyman, Phelps & McNamara, P.C.s

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Drug Pricing 59

European Pharmaceutical Review

OCTOBER 19, 2022

2 Recently, the US Patent and Trademark Office (US PTO) reiterated the concern that patents have been “misused to inhibit and delay – for years and even decades – competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.” Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book.

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Biosimilars Dosage Drug Pricing Pharmaceutical Companies 96

FDA Law Blog: Biosimilars

MARCH 18, 2025

The question is important because the result of that determination could drastically reduce the amount of patent term to be restored.

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Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 59

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.,

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Biosimilars Dosage 59

pharmaphorum

JUNE 24, 2021

The original formulation has started to lose patent protection however, and a gaggle of drug developers – including Samsung Bioepis/Biogen, Hospira and Formycon/Bioeq – are already preparing to enter the US market with lower-cost biosimilars , with the first rivals expected to launch before year-end. Last year, Roche booked around $1.5

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Diabetes Biosimilars Drug Development 95

FDA Law Blog: Biosimilars

NOVEMBER 7, 2023

” At least that’s this blogger’s reaction to the recent news that FTC sent out Notice letters to 10 different drug companies about the patent information they list in the Orange Book. As FTC explains in a Press Release , the Agency “challenged more than 100 patents” that it believes are improperly or inaccurately listed in the Orange Book.

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Dosage 59

FDA Law Blog: Biosimilars

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. Rather, the FTC questioned whether these patents meet the statutory and regulatory criteria for listing in the Orange Book.

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Dosage 45

FDA Law Blog: Biosimilars

JUNE 12, 2024

The ideal candidate will have a book of business. Strong verbal and writing skills are required. Partner/director, counsel and senior associate level attorneys with the requisite substantive experience are encouraged to apply. Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer.

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Department of Veterans Affairs 59

FDA Law Blog: Biosimilars

MARCH 29, 2023

The OTC approval of NNS will not change the prescription status of the 21 injectabl e naloxone products listed in the Orange Book. However, additional naloxone products will remain prescription drugs. Additionally, 8 mg naloxone nasal spray (N212045) is also still a prescription drug.

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Labelling 105

FDA Law Blog: Biosimilars

FEBRUARY 4, 2025

First, the Tropical Disease PRV program is the oldest one on the books and was the only one that was drafted without a sunset clause. While lapse of this program may raise concerns about the end of the Tropical Disease PRV, such a result is highly unlikely.

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Vaccines 52

FDA Law Blog: Biosimilars

SEPTEMBER 23, 2024

For the 40th anniversary of the Orange Book (and the quasi-35th anniversary of Hatch-Waxman), we put together a public Orange Book Archive (and it has become one of the more popular stops on the FDA Law Blog). For the 25th and 30th anniversaries, we held trivia contests ( here and here ).

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Dosage Drug Pricing 59

FDA Law Blog: Biosimilars

JULY 24, 2024

Join us to address emerging and growing areas of concern, including the implementation of the Inflation Reduction Act, FTC’s—and now a District Court’s—attack on Orange Book patent listings, and the proposed use of the Bayh Doyle Act. s Kurt R.

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FDA Law Blog: Biosimilars

MAY 11, 2023

Where the generic sponsor has carved-out the specific indication identified in the Orange Book as covered by the method of use patent, the Government argues, the generic labeling “cannot provide the requisite evidence of specific intent to induce infringement.”

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Labelling Documentation Communication 72

PharmaShots

FEBRUARY 27, 2023

Addepalli Veeranjaneyulu and Shubhadeep Debabrata Sinha introduced the session by describing the function of PV in the safety profiles of biosimilars. To provide the audience with an Indian viewpoint, the presenters pointed out the country's requirements for biosimilar PV.

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Biosimilars Diabetes Packaging Hospitals 40

RX Note

FEBRUARY 23, 2023

Rx & Calc - TDM calculator via Microsoft Excel and Open as App Learning Module - Questions bank for PRP training Optimizing PDF (eBooks) - Teach you how to create bookmarks in PDF for faster navigation Pilleye - Pill counting app Add Website to Home Screen - For fast access QR Code, Shorten URL and Links in One Place - Discussing some useful tools (..)

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

FDA Law Blog: Biosimilars

JANUARY 8, 2025

Koblitz Whether a patent can be listed in the Orange Book is a critical issue for both brand and generic manufacturers, and, of particular interest in the last few years is whether patents claiming just the device constituent of a combination product is eligible for listing. Nine patents are listed in the Orange Book with ProAir HFA.

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FDA Law Blog: Biosimilars

JANUARY 1, 2025

More specifically, the bill states that these activities shall not be acts of direct, induced, or contributory infringement of a method of use claim in a patent listed in the Orange Book. The safe harbor applies only when the labeling, promotion, or commercial marketing does not reference the condition(s) of use claimed in the patent.

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Labelling Biosimilars 105

Express Pharma

JANUARY 1, 2025

It also manufactures and sells complex specialised fermentation-based Active Pharmaceutical Ingredients (APIs), including probiotics, enzymes, peptides, nutritional actives, vitamin analogues and biosimilars. Its revenue from operations increased by 34.3 per cent to Rs. 1,419 crores in Fiscal 2024 from Rs. 1,056 crores in Fiscal 2023.

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Biosimilars Drug Development 105

Big Molecule Watch

DECEMBER 31, 2024

They recognize that larger patent portfolios have proved valuable in delaying biosimilar competition. Of course, the biosimilar manufacturer ultimately controls the number of patents asserted in BPCIA litigation via 42 U.S.C. More recently, RPSs have asserted device patents, and even design patents, for example, in Regeneron v.

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Biosimilars 59

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents. CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc.

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Documentation Packaging Clinical Pharmacology Drug Development 59

pharmaphorum

JULY 8, 2022

” The document says that AbbVie booked 99% of its 2020 prescription drug sales income through its foreign subsidiaries, when 75% of it was made in the US. Now, it’s turning its attention to other big pharma groups, including Abbott Laboratories, Merck & Co and reportedly also Bristol-Myers Squibb.

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Biosimilars Documentation 59

FDA Law Blog: Biosimilars

JANUARY 9, 2024

Kirschenbaum — The law permitting the importation of cheaper prescription drugs from Canada—Section 804 of the Federal Food, Drug, and Cosmetic Act (FDC Act)—has been on the books for decades.

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