FDA Law Blog: Biosimilars

JULY 18, 2023

Claud — The Office of Pharmaceutical Quality (OPQ), located within FDA’s Center for Drug Evaluation and Research (CDER), uses global inspection, surveillance, policy, and research activities to set quality standards for drugs. Consistent with that initiative, OPQ recently issued its 2022 Annual Report on the State of Pharmaceutical Quality.

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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.

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Drug Discovery World

FEBRUARY 22, 2024

trillion on 31 December 2022 to $3.67 Out of the top 20 players, nine companies indicated positive growth in stock market value, with four companies – Lilly (59.2%), Novo Nordisk (51.5%), Vertex Pharmaceuticals (41.4%) and Regeneron Pharmaceuticals (21.8%) – reporting more than 20% YoY growth in market capitalisation.

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Drug Channels

OCTOBER 10, 2023

I am pleased to announce our new 2023–24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. pharmaceutical distribution industry. addresses the Inflation Reduction Act of 2022. and Section 6.4.3. A new Section 6.2.2. A new Section 6.3.2.

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Drug Channels

SEPTEMBER 17, 2024

On October 8, 2024, Drug Channels Institute will release our 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. pharmaceutical distribution industry. This report—our fifteenth edition—remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S.

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The Pharma Data

MARCH 13, 2022

NYSE: PFE) announced today the completion of its acquisition of Arena Pharmaceuticals, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases. Pfizer Inc. For additional background on the acquisition, please read the announcement press release here.

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Drug Discovery World

JULY 25, 2023

The pharmaceutical industry is constantly developing evidence-based treatments for children while there continue to be scientific advancements related to new modalities and disease understanding. General clinical pharmacology This FDA draft guidance was previously issued in 2014 but was re-issued for comments again in 2022.

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FDA Law Blog: Biosimilars

JUNE 17, 2024

Claud — FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. Last week, OPQ released its 6th Annual Report on the State of Pharmaceutical Quality. to maintain its gold standard of pharmaceutical quality. By Kalie E.

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The Pharma Data

APRIL 4, 2023

Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. It has a leading global portfolio with eight marketed biosimilars and a further 15+ in various stages of development. Source link: [link]

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Drug Channels

JULY 11, 2022

September 14-15, 2022 Sheraton San Diego Hotel & Marina | San Diego, CA www.informaconnect.com/hub-specialty-pharmacy-west. Copyright © 2006-2022 Pembroke Consulting, Inc. Informa Connect's Hub and Specialty Pharmacy Models West. Delivered as a Hybrid Event. O’Brien, Pharm. Drug Channels, or any of its employees.

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Drug Discovery World

OCTOBER 20, 2022

Japan continues to be one of the largest pharmaceutical markets in the world, despite what the International Trade Administration described as ‘a challenging business landscape due to demographics’ 1. Similarly, biosimilars are expected to grow. The vision has four priorities: . Regulatory .

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Drug Discovery World

MARCH 29, 2023

From the industry perspective, that process has begun with the public commitment already in 2022 to file for pricing and reimbursement in all member states within two years of getting approval and documenting progress in a portal. He pointed out that Europe was the first region to approve biosimilars. You can compare timelines.

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FDA Law Blog: Biosimilars

APRIL 21, 2024

Taiho Pharmaceutical Co., But that’s the controversy here: Did FDA approve LYTGOBI NDA 214801 on September 30, 2022 when the Agency issued its initial approval letter , or on October 5, 2022 when FDA issued a corrected approval letter ? which brings us to the topic of this post. Patent Nos. Patent Nos.

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Agency IQ

JANUARY 19, 2024

For example, in 2023, the EMA published its 2022 highlights report on February 16, followed by the detailed report on May 15. Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. This most recent year saw 80 total opinions, compared to 92 in 2022 and 97 in 2021. for the years 2020 to 2022.

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FDA Law Blog: Biosimilars

APRIL 8, 2024

Claud — CDER’s Office of Pharmaceutical Quality (OPQ) issued its 2023 Annual Report last week, and it’s an upbeat assessment of the Office’s policy and outreach efforts. Last year, OPQ saved a more quantitative analysis of its efforts for the other yearly publication it put out, on the State of Pharmaceutical Quality. By John W.M.

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FDA Law Blog: Biosimilars

AUGUST 14, 2024

Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers. Kirschenbaum & Michelle L. Butler & Faraz Siddiqui & Sophia R.

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Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. increase at constant currency compared to the corresponding period in 2022. increase on a reported basis and an 4.8%

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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. What led to NPA’s lawsuit?

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Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). Labcorp, IQVIA, ICON, and WuXi Clinical (based on 2022 annual revenue). By geographical region, the global CRO services market in 2023 was dominated by North America. with full-year revenue of US$23.04 with US$23.04

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DrugBank

AUGUST 9, 2024

Investment Trends in Pharmaceutical Research and Development Investing in the pharmaceutical sector presents a unique set of challenges and opportunities; let’s examine them in more detail.  Pharmaceutical Market Analysis The global pharmaceutical market revenue in 2024 is projected to be 1.15

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Agency IQ

AUGUST 2, 2024

By Alexander Gaffney, MS, RAC | Aug 31, 2022 6:50 PM CDT | Updated Jul 29, 2024 9:45 PM CDT What we expect to be talking about in August and September The end of the fiscal year (and a budget showdown or shutdown) : The last day of the government’s fiscal year is September 30, which will mark an especially busy period for the FDA.

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The Pharma Data

MAY 15, 2023

Before joining Nestlé he served as CFO at Takeda Pharmaceuticals, one of the largest publicly listed companies in Japan, between 2013 and 2015, and CFO at Millicom, a NASDAQ listed global mobile phone operator based in Luxembourg, between 2008 and 2013. Urs Riedener, was CEO of Swiss consumer goods company EMMI Group between 2008 and 2022.

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The Pharma Data

MAY 2, 2022

Teva Branded Pharmaceutical Products R&D, Inc. and Auspex Pharmaceuticals, Inc., affiliates of Teva Pharmaceutical Industries Ltd. On March 9, 2022, the U.S. Teva Pharmaceutical Industries Ltd. Prescribers should be aware of the possibility of long-term ophthalmologic effects. About Teva.

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Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials.

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FDA Law Blog: Biosimilars

AUGUST 16, 2023

Mr. Godwin’s presentation made the same point, although with more data to back it up: so far this fiscal year (since October 1, 2022), the number of OAI inspections resulting in the exercise of regulatory discretion is unusually high.

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FDA Law Blog: Biosimilars

AUGUST 14, 2023

FDA also looked at how may of the Active Pharmaceutical Ingredients for those drugs were manufactured overseas. Farquhar — At the GMP by the Sea Conference ongoing in Cambridge, Maryland, a presentation was made by a representative of FDA’s Center for Drug Evaluation and Research that shows some interesting trends in enforcement.

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FDA Law Blog: Biosimilars

SEPTEMBER 23, 2024

Hatch passed away in April 2022), but Eli Mazour’s Clause8 podcast from October 2018 already covered that ground: see Henry Waxman – The Hatch-Waxman Act and a Life In Congress. We thought about an interview with Rep. Waxman (sadly, Sen. We wanted something different. something useful to Hatch-Waxman practitioners.

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FDA Law Blog: Biosimilars

JANUARY 1, 2024

We are unable to determine whether the number of such Warning Letters issued during the entire year represents a significant increase over 2022. The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022.

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FDA Law Blog: Biosimilars

MARCH 26, 2024

Last time, back in 2022 , the FTC took on REMS patents, explaining in litigation between Jazz and Avadel that the listing of REMS patents in the Orange Book is anticompetitive; this time, the FTC is going after device patents. Koblitz — The FTC appears to be on a mission to cleanse the Orange Book of patents it deems improperly listed.

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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. Expected Action Description of action Original Deadline Pharmaceuticals – changes to marketing authorisations (review of EU rules) [E.U.] Q2 2022 E.U.

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The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.

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Agency IQ

JUNE 2, 2023

In 2022 and 2021, the Spring Unified Agenda was released in early/mid June. 6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., not discontinued) and are available for sale.

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The Pharma Data

MARCH 5, 2021

Novartis plans to produce up to 50 million doses of the mRNA and bulk drug product for the CureVac vaccine in 2021 and up to a further 200 million doses in 2022. At the Kundl site, Novartis is a pioneer and has decades of experience in pharmaceutical production of proteins and in more recent years of nucleic acids.

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Agency IQ

JULY 8, 2024

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED JUN 28, 2024 6:45 PM CDT What we expect to be talking about in July and August Chevron Shakeout : Just how soon will it take for companies to begin attacking FDA over the recent Loper Bright Supreme Court case overturning the Chevron Doctrine? and the E.C.

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FDA Law Blog: Biosimilars

MARCH 24, 2024

On December 12, 2022, the district court granted intervenors’ motion for summary judgment, holding that federal law did not preempt the Arkansas statute under any theory. Code Ann. § 23-92-604(c)(1), (2) (Act 1103). On March 12, 2024, a three-judge panel of the Eighth Circuit affirmed. & Mfrs. McClain , No. 22-3675, 2024 U.S.

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Agency IQ

AUGUST 2, 2024

For example, the German medtech trade organization (BVMed) is hosting a webinar on September 9 to offer industry an overview of the upcoming launch of upcoming cybersecurity policy, European NIS-2 Directive ( EU 2022/2555 ) that aims to harmonize cybersecurity measures across the E.U

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FDA Law Blog: Biosimilars

MARCH 13, 2024

is expressly authorized to rely upon the regulatory review activities by Pfizer Ireland Pharmaceuticals (Pfizer), the marketing applicant before the Food and Drug Administration to support the application for patent term extension of U.S. . § 1.750, applicant is required to submit the following to the Office: Evidence that Opko Biologics Ltd.

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