FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

As a reminder, devices with preamendment status are those that were legally marketed in the US before May 28, 1976, have not been significantly changed since May 28, 1976, and for which a regulation requiring a premarket approval application has not been published. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway.

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FDA Law Blog: Biosimilars

MAY 30, 2024

In 2010, the Health Resources and Services Administration (HRSA) authorized covered entities to contract with an unlimited number of retail pharmacies to fill prescriptions for their patients. Initially, drug manufacturers were required to offer these discounts only to the in-house pharmacies of covered entities.

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FDA Law Blog: Biosimilars

OCTOBER 19, 2023

DEA has held Drug Take Back Days each spring and autumn since 2010. DEA is not a band, but along with its law enforcement partners, the agency will host thousands of local drop-off locations nationwide for clearing out and proper disposal of expired and unneeded medication from medicine cabinets between 10:00 am to 2:00 p.m.

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FDA Law Blog: Biosimilars

APRIL 16, 2024

To address concerns that manufacturers were making minor changes to drugs in order for them to be characterized as new covered outpatient drugs with updated (and higher) baseline AMPs, Congress amended the statute in 2010 to add an alternative rebate for line extensions of oral dosage form single source or innovator multiple source drugs (i.e.,

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FDA Law Blog: Biosimilars

AUGUST 18, 2024

Since 2010, FDA has posted classification orders and decision summaries for devices classified through the De Novo classification process. These summaries can be invaluable to companies that want to get their own clearance, providing the details that can be the key to understanding what the recipient of the De Novo did.

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Agency IQ

JUNE 9, 2023

countries examined between 2010 and 2017. Reduced market exclusivity would foster generic and biosimilar competition through earlier market access. The reduction from the current 10 years to either 9 or 5 years would allow earlier entry of generics and biosimilars. The launch of a product across the E.U.

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FDA Law Blog: Biosimilars

APRIL 3, 2023

In 2010, concerned that manufacturers were making minor changes to a drug merely so that it could be characterized as new covered outpatient drug with an updated baseline AMP, Congress added to the statute an alternative rebate for line extensions of oral dosage form innovator (i.e., NDA or BLA) drugs.

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

We recount a few milestones along the road here: 1997 ASR Rule restricts sale, distribution of analyte specific reagents; FDA asserts authority over LDTs but articulates enforcement discretion policy 1998 FDA denies Citizen Petition submitted in 1992 on behalf of several clinical laboratories challenging agency authority over “home brew” tests 2006 (..)

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

2010) , however, the U.S. For several years, the PTO interpreted the term “product” to mean “active moiety” rather than “active ingredient” ( i.e. , the ion or molecule, excluding salts, esters, etc., responsible for the pharmacological action of a drug, instead of the ion or molecule including salts, esters and other derivatives).

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Agency IQ

SEPTEMBER 1, 2023

Consultation question 2: “Do you think the proposals could impact people differently with reference to their protected characteristics covered by the Public Sector Equality Duty set out in section 149 of the Equality Act 2010 or by section 75 of the Northern Ireland Act 1998? If so, please provide details below.” reference product.

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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. Developing biosimilars is an extensive and expensive process.

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The Pharma Data

MARCH 30, 2021

Founded in 2010 with a vision to make childbirth safer for all mothers, Alydia Health is a commercial-stage medical device company focused on preventing maternal morbidity and mortality caused by postpartum hemorrhage (PPH) or abnormal postpartum uterine bleeding – a challenging condition to manage and a growing problem in the U.S.

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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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FDA Law Blog: Biosimilars

APRIL 13, 2023

DEA’s bi-annual Take Back Days have collected nearly 17 million pounds of medication since 2010. DEA’s Take Back Day last October collected almost 650,000 pounds of unneeded medication at about 5,000 collection sites. More information about DEA’s National Prescription Drug Take Back Day, including disposal locations, can be found at: [link].

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The Pharma Data

JULY 15, 2021

UK Biobank recruited 500,000 people aged between 40-69 years in 2006-2010 from across the UK. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp.

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The Pharma Data

JULY 8, 2021

UK Biobank recruited 500,000 people aged between 40-69 years in 2006-2010 from across the UK. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp.

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Agency IQ

JUNE 2, 2023

These prototypes, and the intended form and function of a PMI for prescription drugs, were further refined in a series of workshops with the Brookings Institute between 2010 and 2014. Implementation of the rule would take place over a five-year period, intended to give companies ample time to develop and obtain approval for PMIs.

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FDA Law Blog: Biosimilars

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. By 2010, about 2000 isolated human genes had been patented in the U.S.

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FDA Law Blog: Biosimilars

OCTOBER 20, 2024

million pounds of medication since 2010. Last April’s Take Back Day collected over 670,000 pounds of unneeded medication at 4,900 collection sites nationwide. DEA has collected over 18.5 More information about National Prescription Drug Take Back Day, including disposal locations, can be found here.

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