Pharmaceutical Technology

MARCH 24, 2023

Biosimilars for AbbVie’s (US) Humira (adalimumab) have finally launched in the US, bringing an end to Humira’s 20-year reign as the best-selling biologic of all time. Biosimilars are an important tool to facilitate competition, lower the price of drugs, and create savings across the board.

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Biosimilars 59

Safe Biologics

FEBRUARY 1, 2024

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability. Comments may be submitted here until April 30, 2024.

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pharmaphorum

MAY 12, 2021

Biosimilars firm Alvotech has filed a lawsuit that challenges AbbVie’s legal defences surrounding the inflammatory disease drug Humira in the US. Humira is due to face competition from a gang of cheaper biosimilar near-copies in 2023, when the blockbuster drug’s patent protection runs out in the US.

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Pharmacy Times

JULY 17, 2023

FDA approvals of these biosimilars started in 2016, but only 1 such product has successfully launched.

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Biosimilars 49

Safe Biologics

JUNE 6, 2024

Executive Director Michael Reilly also attended the conference, where he met with representatives of the cancer community and discussed the IRA’s likely negative impacts on cancer drug research and development, biosimilar competition, and patient access to new innovative therapies. View the resource guide here.

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PharmaShots

FEBRUARY 1, 2023

Shots: The company has launched Amjevita (adalimumab), the first biosimilar referencing blockbuster drug Humira on the US market for certain serious inflammatory diseases. Amjevita will be available in a prefilled syringe & auto-injector pen Amjevita (40mg) is available with 2 pricing options.

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Biosimilars 40

PharmaShots

MARCH 1, 2023

In preclinical studies, HLX15 is highly similar to daratumumab Amgen Launches First Humira (adalimumab) Biosimilar Amjevita in the US Date- February 01, 2023 Product: Amjevita The company has launched Amjevita (adalimumab), the first biosimilar referencing blockbuster drug Humira on the US market for certain serious inflammatory diseases.

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Big Molecule Watch

FEBRUARY 6, 2025

Samsung) and Formycon AG (Formycon) from marketing their aflibercept biosimilars of EYLEA . 2016) and stated that the filing of an aBLA, service of a Notice of Commercial Marketing, and establishment of a distribution channel were sufficient to establish minimum contacts. Mylan Pharmaceuticals Inc. , 3d 755 (Fed.

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Biosimilars 59

Big Molecule Watch

OCTOBER 28, 2023

The FDA approved Celltrion’s infliximab biosimilar, administered by intravenous infusion, in April 2016 under the trade name INFLECTRA (infliximab-dyyb). The post Celltrion Announces FDA Approval of ZYMFENTRA (infliximab-dyyb) appeared first on Big Molecule Watch.

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Biosimilars 59

Pharmaceutical Technology

FEBRUARY 3, 2023

However, after almost seven years of staving off competitors through patents and litigation, Humira’s market-leading position in the US will be affected as Amgen’s adalimumab biosimilar, Amjevita, started to roll out on January 31, 2023. According to GlobalData estimates, in 2022, the adalimumab biosimilars market was valued at $184.2

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Drug Patent Watch

JANUARY 7, 2025

“2021 Generic Drug & Biosimilars Access & Savings in the U.S. ” JAMA, 2016. Association for Accessible Medicines. ” AccessibleMeds.org, 2021. Kesselheim, A.S., “The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform.” World Health Organization.

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pharmaphorum

OCTOBER 28, 2022

She is an SME in market access, rare disease and biosimilars. Nina gained her MSc in Health Policy from Imperial College London in May 2016 and is a trustee for the Waldenström’s Macroglobulinemia UK charity. Nina Pinwill BSc (Hons) MSc DIC, is the Head of Commercial Operations at NHS England and NHS Improvement.

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Biosimilars 122

Express Pharma

JUNE 28, 2024

This was followed by a session on regulatory reforms by Chandrasekhar Ranga, Joint Drugs Controller, Government of India , and Susana Almeida, Secretary General, International Generics and Biosimilar Association (IGBA); and on talent acquisition strategies, and skilling institutes for quality manufacturing by Global CHROs and Manufacturing Heads.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”

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Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Frequent amendments (1998–2016). For example: Reduced stay.

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Biosimilars Dosage Documentation 52

Big Molecule Watch

JANUARY 25, 2024

As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. The approval of Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to Janssen’s STELARA (ustekinumab) is noteworthy given that it received designation as interchangeable. Below are some of the top regulatory developments from 2023.

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Pharma in Brief

APRIL 29, 2021

At the end of 2016, the previous Quebec government prohibited a number of common commercial practices by drug manufacturers and pharmacists with the aim of fostering greater price competition between drug manufacturers and reducing the cost of the public drug insurance scheme. [1]. The lowest price method also does not apply to biosimilars.

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Biosimilars 52

Express Pharma

OCTOBER 16, 2024

Biocon Biologics gained EMA approval to manufacture biosimilar Bevacizumab at its advanced facility in Bengaluru, enhancing its credibility internationally. ABX-CRO, with ISO 9001:2015 and ISO 13485:2016, exemplifies how these standards can be integrated (13).

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Big Molecule Watch

APRIL 12, 2023

Further, the complaints alleged that, when Pfizer launched its competing INFLECTRA (infliximab-dyyb) in 2016, J&J “deployed improper exclusionary tactics to maintain the dominance of its flagship product.” Discovery in the indirect-purchaser antitrust actions were consolidated with discovery in the antitrust action brough by Pfizer.

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Biosimilars 72

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Under the agreement, Celltrion will exclusively supply to Rani the ustekinumab biosimilar drug substance (CT-P43) required for its RT-111 programme. Rani recently partnered with Celltrion for the development of RT-111.

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FDA Law Blog: Biosimilars

MARCH 10, 2024

Likely discussion topics during the session will address what has changed since 2016 when FDA/HHS and DEA concluded that cannabis remain in schedule I, why DEA may be required under U.S. Houck will participate in a session entitled “Marijuana Rescheduling: Exploring FDA’s Recommendation, Stakeholder Impact, and Broader Implications.”

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Controlled Substances 64

FDA Law Blog: Biosimilars

JULY 31, 2023

Houck — President Barack Obama signed the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) intended to reverse serious prescription drug abuse trend in the United States on July 22, 2016. By Larry K.

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

In the most recent eight factor analyses prior to August 2023, in 2016 HHS and DEA concluded that marijuana continued to meet criteria for remaining in schedule I. 12, 2016); Denial of Petition To Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition To Initiate Proceedings to Reschedule Marijuana, 81 Fed.

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FDA Law Blog: Biosimilars

NOVEMBER 27, 2023

At the time, in 2016, the Gree Companies’ settlement for $15.45 DOJ’s enforcement against the Gree Companies and its executives occurred in stages. First, as is more common under the CPSC, the Gree Companies agreed to pay civil penalties for failing to make the required reporting to the CPSC.

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FDA Law Blog: Biosimilars

APRIL 22, 2024

When DEA denied marijuana rescheduling petitions in August 2016, cannabis was listed as a schedule I and schedule IV substance under the Single Convention. . § 811(d) required classification of marijuana as a schedule I or II substance to comply with U.S. On a final note, as a signatory to the Single Convention, U.S. 811(d) and U.S.

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Controlled Substances 59

Big Molecule Watch

JANUARY 19, 2024

As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and developments in the biosimilars and biologics space in 2023 that we covered on the Big Molecule Watch.

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Biosimilars Dosage Drug Pricing 58

European Pharmaceutical Review

JULY 4, 2024

2 It was first approved as Fulyzaq in December 2012 and in October 2016, Napo Pharmaceuticals launched the new brand, Mytesi. The second was crofelemer, Mytesi , an indicator drug for HIV-associated diarrhoea extracted from the blood-red latex of the South American croton tree. 3 Is two too few? BMB Reports. 2017;50(3):111–6.

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Drug Development Biosimilars Documentation Labelling 103

FDA Law Blog: Biosimilars

JANUARY 18, 2024

In 2016, FDA again threatened to remove it , but ultimately took no action for reasons that remain unclear. At that time, the Agency allowed it to stay on the market under a program that tested edible portions of pigs, a method FDA now claims is not sufficient.

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Communication 59

FDA Law Blog: Biosimilars

APRIL 25, 2023

Note that section 3060(a) of the 21st Century Cures Act in 2016 amended section 520 of the FD&C Act and removed certain software functions from the statutory definition of a medical device. It applies whether the software is the entire device (i.e., Software in a Medical Device, or SiMD).

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

In 2016, FDA determined that e-cigarettes and their component parts fell under the term “new tobacco products,” requiring manufacturers of such products to submit PMTAs for FDA review before the Agency would issue a marketing order permitting the legal sale of the product.

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Documentation 115

FDA Law Blog: Biosimilars

MAY 22, 2023

Voters in Massachusetts approved a ballot initiative (Question 3) in 2016 that imposed requirements similar to those imposed under Proposition 12. California is not the only state to have established animal welfare requirements affected by the Supreme Court’s decision.

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Documentation 45

FDA Law Blog: Biosimilars

JULY 6, 2023

We now see that the proposed rule to “harmonize and modernize” the QSR with ISO13485:2016, creating the new QMSR, is on the Spring 2023 Unified Agenda (see here ). According to the Unified Agenda, the proposed rule is in the final rule stage. The final rule’s publication is a “high priority”, according to Dr.

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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

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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Hospitals Immunity Immunization 81

FDA Law Blog: Biosimilars

APRIL 21, 2024

After all, as we posted in 2016 , there have been approval date resets under certain circumstances. But there may be more out there. So we’ll sit tight to see whether or not Taiho takes the next step of litigating the issue.

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Labelling Controlled Substances 59

pharmaphorum

FEBRUARY 23, 2022

Adoption of biosimilars in the US has been notoriously slow, but biosimilars manufacturers and outside observers expect this to change rapidly in the coming years. One way in which the pharmaceutical industry and regulators have reacted is by developing or facilitating the development of biosimilars. The short story so far.

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Biosimilars Vaccines 98

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

8,128,929 was submitted on December 8, 2016 (Docket No. FDA-2017-E-5106 ), and concerns FDA’s October 19, 2016 Accelerated Approval of BLA 761038 for LARTRUVO (olaratumab). 8,128,929 [] for [PTE] request under 35 U.S.C. § The PTE application for U.S.

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Documentation 59