FDA Law Blog: Biosimilars

JANUARY 11, 2024

HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico. Two Hyman, Phelps & McNamara, P.C.

Pharmaceuticals

The Pharma Data

OCTOBER 18, 2021

under a cooperative development and license agreement. Tofersen is also being studied in the Phase 3 ATLAS study, which is designed to estimate the capability of tofersen to delay clinical onset when initiated in presymptomatic individualities with a SOD1 inheritable mutation and biomarker substantiation of complaint exertion.

Biosimilars

The Pharma Data

SEPTEMBER 16, 2020

16, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) announced today that data from its oncology pipeline in solid tumors will be presented during the European Society of Medical Oncology (ESMO) Virtual Congress 2020, Sept. Amgen will present new data for AMG 510 (proposed INN: sotorasib) and AMG 160 during two oral presentations.

Clinical Trials

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

FDA Law Blog: Biosimilars

AUGUST 9, 2023

Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. Two licensed pharmacists must directly communicate the transfer. By Larry K. The content and prescription information elements required by 21 C.F.R.

Pharmacy

Agency IQ

SEPTEMBER 22, 2023

The goal of the framework , as described in a 2019 presentation from FDA staff on the subject, is to “provide prescription drug sponsors the flexibility to disseminate innovative software, while maintaining appropriate Agency oversight over the sponsors’ communications about their products.” This would be considered a type of drug labeling.

FDA

FDA Law Blog: Biosimilars

JULY 5, 2023

Under section 503B, drugs compounded by an FDA-registered outsourcing facility under the supervision of a licensed pharmacist can qualify for exemptions from FDA approval, labeling with adequate directions for use, and certain drug supply chain security requirements, subject to specific conditions. Draft Guidance III.B.2(e)

FDA

The Pharma Data

SEPTEMBER 20, 2020

Data from 59 patients with advanced non-small cell lung cancer reported in the NEJM manuscript were also featured today during an oral presentation at ESMO 2020. Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C ?inhibitor

Clinical Trials

Agency IQ

JUNE 29, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

FDA

The Pharma Data

APRIL 30, 2021

percent on an operational basis, due to biosimilar competition. “Operational” comparisons are presented at constant currency rates and reflect comparative local currency net revenues at the prior year’s foreign exchange rates. . Humira net revenues were $3.907 billion , an increase of 6.9

FDA

The Pharma Data

JULY 27, 2021

We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected.

Production

The Pharma Data

NOVEMBER 9, 2020

Results from the NAVIGATOR trial will be presented at an upcoming medical meeting. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Type 2 inflammation in asthma–present in most, absent in many. J Allergy Clin Immunol. 2014; 133: 388–94. 15 Fahy JV.

Trials

Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Law Blog: Biosimilars

JUNE 27, 2024

Coconut Grove had noted “verified” on the prescriptions which DEA found “is not sufficient to identify and resolve any red flags that may be present.” It also states that “[t]he pharmacist shall record any related information indicated by a licensed health care practitioner.” Id. at § 64B16-27.800(2).

Pharmacy

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. In seeking to justify regulation of LDTs, FDA emphasizes that many of these tests are novel. [6] By their very nature, these tests are less likely to be exempt from FDA review.

FDA

The Pharma Data

OCTOBER 29, 2020

ALXN2060 (AG10) – Eidos: Alexion holds an exclusive license to develop and commercialize ALXN2060 (AG10) in Japan. Enrollment is underway in two parallel Phase 3 studies – one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease. Eidos is currently evaluating AG10 in a Phase 3 study in the U.S.

Clinical Trials

The Pharma Data

DECEMBER 21, 2020

Detailed results from the SOURCE trial will be presented at a future medical meeting. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Further analyses of the data are ongoing. The safety profile of tezepelumab in the trial was consistent with previous trials.

Trials

The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

Biosimilars

Drug Channels

FEBRUARY 22, 2022

We also present a more unified outlook for specialty drugs, including specialty generics and biosimilars. If you have any questions before purchasing a license to the report, please email me. Download a free report overview for more details. The chart below illustrates the depth and breadth of the 2022 edition.

Pharmacy

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.

Biosimilars

Agency IQ

JUNE 2, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

FDA

Agency IQ

OCTOBER 27, 2023

Government shutdown: At present, the U.S. Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. Expect nearly every company to be closely reading this document when it’s eventually published.

FDA

The Pharma Data

NOVEMBER 6, 2020

and 5 yes, 0 no and 6 uncertain on the question, “Has the Applicant presented strong evidence of a pharmacodynamic effect of aducanumab on Alzheimer’s disease pathophysiology?”. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. About Aducanumab.

Disease

Agency IQ

JULY 28, 2023

June 2023 Final Rule Stage Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format The Food and Drug Administration (FDA) is amending its regulations concerning direct-to-consumer (DTC) advertisements of prescription drugs.

FDA

The Pharma Data

AUGUST 3, 2021

Certain financial information for 2021 and 2020 is presented on both a reported and a non-GAAP basis. The non-GAAP measures are presented to provide additional insights into the underlying trends in the company’s business. 30% Non-GAAP guidance reflects adjustments presented in the earnings per share table above.

Production

FDA Law Blog: Biosimilars

MARCH 13, 2024

The PTE application states “[u]nder the terms of the AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION LICENSE AGREEMENT between Pfizer Inc. exclusively licensed U.S. However, an exclusive license is not an authorization to rely on the activities of the marketing applicant for a PTE application. and OPKO Ireland Ltd.

FDA

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. Priority B List.

FDA

The Pharma Data

OCTOBER 29, 2020

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. You should not place undue reliance on these statements or the scientific data presented. Since October 2017 Biogen and Eisai Co., have collaborated on the development and commercialization of aducanumab globally.

Disease

The Pharma Data

DECEMBER 9, 2020

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. You should not place undue reliance on these statements or the scientific data presented. Since October 2017 Biogen and Eisai Co., have collaborated on the development and commercialization of aducanumab globally.

Clinical Trials

Agency IQ

MAY 3, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA

Agency IQ

JUNE 2, 2023

In 2009, the agency held a workshop to discuss the gaps in existing frameworks and present some new options for discussion, including four “prototypes” of potential PMIs. However, only licensed blood establishments would be required to submit PMI to FDA for approval.”

FDA

Agency IQ

SEPTEMBER 29, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

FDA

FDA Law Blog: Biosimilars

MAY 21, 2024

The Attorney General, after considering HHS’ recommendations, “concludes that there is, at present, substantial evidence that marijuana does not warrant control under schedule I.” The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM. NPRM at 44,619.

Regulations

The Pharma Data

FEBRUARY 8, 2021

In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. price, patients switching to Toujeo ® and biosimilar glargine competition. driven by Rest of the World sales growth which more than offset biosimilar competition in Europe.

Vaccine

The Pharma Data

FEBRUARY 4, 2021

In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. price, patients switching to Toujeo ® and biosimilar glargine competition. driven by Rest of the World sales growth which more than offset biosimilar competition in Europe.

Vaccine

Agency IQ

DECEMBER 1, 2023

Government shutdown: At present, the FDA has appropriated funding through January 19. Both sections 503A and 503B provide that a compounded drug is not eligible for those exemptions if it is identified by FDA as presenting demonstrable difficulties for compounding.

FDA

The Pharma Data

APRIL 27, 2021

net price, increasing usage of Toujeo ® , biosimilar glargine competition and lower sales in Europe (patient stockpilling in the first quarter of 2020). On January 12, 2021 Sanofi entered into a global licensing agreement with Biond Biologics for BND-22, a novel immune checkpoint inhibitor targeting the ILT2 receptor. In the U.S.,

Vaccine