FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

FDA-2015-E-2602, FDA-2015-E-2604, FDA-2015-E-2619, and FDA-2015-E-2615), and concern FDA’s July 23, 2014 Accelerated Approval of NDA 205858 and NDA 206545 for ZYDELIG (idelalisib) Tablets for different uses. Patent Nos.

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FDA Law Blog: Biosimilars

SEPTEMBER 26, 2024

The Breakthrough program started in 2015. Manufacturers can expect increased interaction with the review team and prioritized review of the marketing submission.” The reality, however, is quite different. Since that time, CDRH has granted 921 Breakthrough devices, and CBER has granted 12.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Subpart A – General Provisions Subpart A – General Provisions, incorporates by reference ISO 13485:2016 and Clause 3 of ISO 9000:2015 (new § 820.7), and requirements for a quality management system (new § 820.10). The new § 820.10

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FDA Law Blog: Biosimilars

MARCH 8, 2023

Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format. Those who use eSubmitter will notice changes in the electronic 3500A template in the first week of March.

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FDA Law Blog: Biosimilars

AUGUST 11, 2024

This Draft Guidance , withdrawn in 2015, outlines FDA’s historical intent to review submissions and provide comments in a timely manner, “usually within 15 working days of the day the materials are received by FDA.” Years ago, FDA had much more robust communications about promotional materials with sponsors of accelerated approval products.

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Agency IQ

JUNE 29, 2023

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 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.,

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The Pharma Data

NOVEMBER 9, 2020

2015; 15: 57-65. Measures of gene expression in sputum cells can identify TH2-high and TH2-low subtypes of asthma. J Allergy Clin Immunol. 2014; 133: 388–94. 15 Fahy JV. Type 2 inflammation in asthma–present in most, absent in many. Nat Rev Immunol. View original content to download multimedia: [link]. SOURCE Amgen.

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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. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5

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FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

According to the eBay settlement agreement, the government contends that from October 2015 to the present, eBay did not comply with any of “the CSA’s reporting and recordkeeping obligations” involving thousands of transactions. Also, a DEA Form 452 report must be electronically filed within 15 days after the order is shipped.

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Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Reviews of orphan medicines and biosimilars have remained stable over the past three years. There were eight biosimilars reviewed in 2023, which is comparable to 2021 (seven) and 2022 (eight), but lower than 2020, which saw 12 biosimilars reviewed.

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The Premier Consulting Blog

APRIL 25, 2023

This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars. Summary basis of approval (SBA) for Aristada (NDA 207533, 10/5/2015), [link] [accessed 23 March 2023]. 8] US Food and Drug Administration (FDA).

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The Pharma Data

MAY 15, 2023

the world’s largest food company, since 2015. 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.

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FDA Law Blog: Biosimilars

AUGUST 7, 2024

ENTRESTO was approved by FDA in July 2015 “to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.”

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Agency IQ

JULY 28, 2023

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 That would leave 19% of staff affected by furloughs.

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Agency IQ

OCTOBER 27, 2023

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

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FDA Law Blog: Biosimilars

APRIL 7, 2025

Zoetis and Elanco have previously been the target of CVM complaints about their promotion: Of 10 ULs issued by CVM re advertising since 2014, Zoetis received 4 one in 2025, 2023, 2018 and 2016 and Elanco received 2 ULs 1 in 2018 and another in 2015. The allegations in the Warning Letters are serious, but thats not why theyre so interesting.

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

Interestingly, the Plaintiffs alleged that this duty existed when the mother was pregnant in 2015 even though the studies relied upon in the litigation are from 2021. Plaintiffs alleged that Defendants had a duty under state law to warn consumers of a (potential) risk of prenatal exposure to acetaminophen. But we digress.

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Agency IQ

SEPTEMBER 29, 2023

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

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Agency IQ

DECEMBER 1, 2023

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

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FDA Law Blog: Biosimilars

OCTOBER 27, 2024

The recent suit has its origins in FDA’s re-evaluation of its homeopathic enforcement policies , which began at the Agency in 2015 in light of the growth of the industry. In the final guidance, FDA pronounces that homeopathic cures must obtain new drug approvals or exist in the uncertain realm of FDA’s exercise of enforcement discretion.

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FDA Law Blog: Biosimilars

NOVEMBER 8, 2023

The journey began in October 2015 when the President’s Council of Advisors on Science and Technology (PCAST) during the Obama Administration recommended the creation of a class of hearing aids for OTC sale.

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