2018, Biosimilars and FDA Approval - Drug Discovery Digest

2018

Biosimilars

FDA Approval

Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

The Pharma Data

JUNE 17, 2022

Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study Adalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patients Submission builds on Sandoz’ well established biosimilar immunology portfolio in Europe.

Analysis Life Sciences Thank You Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach

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labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products.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

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Chemical Biology and Drug Design

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA. This is a significant jump from any previous year, with the former peak at 15 in FY 2018, followed by several years in the 10-14 range. of all NME approvals this year.

FDA

FDA Biosimilars Science Production

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program.

Science

Science Biosimilars FDA Production

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 1)

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. 2018) , Arnold Partnership v. Another case of same-day (and same-time) FDA approvals!

FDA Approval

FDA Approval FDA Production Therapies

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. for the years 2020 to 2022.

Biosimilars

Biosimilars FDA Production Treatment

Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious

FDA Law Blog: Biosimilars

AUGUST 12, 2024

Since 1991, FDA has taken the position that the testing phase starts when the sponsor submits a request to Center for Veterinary Medicine to establish an INAD file and ends when an NADA is submitted. Plaintiffs performed the necessary studies on BRAVECTO and filed an NADA on April 8, 2014; FDA approved the NADA on May 15, 2014.

FDA

FDA Regulations FDA Approval Drugs

AbbVie Reports Second-Quarter 2021 Financial Results

The Pharma Data

AUGUST 1, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $674 Million; Global Rinvoq Net Revenues Were $378 Million – Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.816 Billion, an Increase of 14.1 percent on an operational basis, due to biosimilar competition.

FDA

FDA Treatment Trials Biosimilars

Lineage Cell Therapeutics Provides End of Year Shareholder Letter

The Pharma Data

DECEMBER 27, 2020

Following changes to our leadership team in late 2018 and early 2019, we have sought to transform Lineage into the preeminent allogeneic cell transplant company. Although our industry has enjoyed many successes lately, those affected by the conditions we are focused on still need better choices.

Therapies

Therapies Clinical Trials Production Treatment

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

APRIL 27, 2021

At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. net price, increasing usage of Toujeo ® , biosimilar glargine competition and lower sales in Europe (patient stockpilling in the first quarter of 2020). First-quarter sales in the U.S.

Vaccine

Vaccine Production FDA Disease

AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results

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

Production

Production Clinical Trials International Small Molecule

FDA accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI

The Pharma Data

APRIL 7, 2023

Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. In the U.S., Ono Pharmaceutical Co.

FDA

FDA FDA Approval Small Molecule Drugs

HHS’ Recommendation to Reschedule Cannabis to Schedule III Raises Questions

FDA Law Blog: Biosimilars

SEPTEMBER 5, 2023

FDA had not approved an NDA or ANDA for cannabis for any indication in 2016. FDA did approve Epidiolex , a cannabidiol oral solution derived from cannabis, in June 2018. Does HHS consider Epidiolex approved for cannabis rescheduling purposes?

FDA

FDA Treatment Drugs FDA Approval

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Vaccine

Vaccine Production FDA Clinical Trials

Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

Analysis Life Sciences Thank You Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach

Trending Sources

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 1)

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious

AbbVie Reports Second-Quarter 2021 Financial Results

Lineage Cell Therapeutics Provides End of Year Shareholder Letter

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results

FDA accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI

HHS’ Recommendation to Reschedule Cannabis to Schedule III Raises Questions

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

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