Drug Channels

DECEMBER 11, 2023

Click here to see the original post from September 2023. CVS Health has finally revealed its strategy for biosimilars of AbbVie’s Humira. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. This week, I’m rerunning some popular posts while I prepare for Friday’s Drug Channels Outlook 2024 live video webinar.

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Big Molecule Watch

AUGUST 24, 2023

In continuation of Goodwin’s previous webinar series concerning biosimilars, Big Molecule Watch is launching the 2023-2024 webinar series , which will dive deep into some of the key topics pertaining to this burgeoning industry and corresponding area of law. The post Biosimilars Webinar Series appeared first on Big Molecule Watch.

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Big Molecule Watch

JANUARY 25, 2024

As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. Below are some of the top regulatory developments from 2023. WEZLANA is the first product to be approved as a biosimilar to STELARA.

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Drug Channels

SEPTEMBER 6, 2023

CVS Health has finally revealed its strategy for biosimilars of AbbVie’s Humira. Rather than announce multiple biosimilars for its pharmacy benefit manager (PBM) formulary, the company will instead launch Cordavis, a new subsidiary that will market a private label, low-list-price version of Sandoz’ Hyrimoz.

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Big Molecule Watch

SEPTEMBER 7, 2023

Developing and successfully commercializing a biosimilar is a complex and expensive process. Topics that will be covered include the 271(e) Safe Harbor, peremptory challenges, labelling and timing considerations, and competitive intelligence. Click here to register for the webinar. Click here to register for the webinar.

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Big Molecule Watch

MAY 20, 2024

Earlier this month, FDA approved Boehringer Ingelheim’s high-concentration (100 mg/mL), citrate-free formulation, CYLTEZO (adalimumab-adbm), a biosimilar to Humira (adalimumab). CYLTEZO was first approved in the US in 2017 and later approved in the US as an interchangeable biosimilar to Humira in October 2021.

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Big Molecule Watch

DECEMBER 28, 2023

According to PWC , “2023 was a reasonably strong year for the pharmaceutical and life sciences sector with both deal value and volume of M&A close to pre-pandemic levels.” Below is a recap of the top M&A deals in 2023 that focus on biologics and biosimilars and were covered on the Big Molecule Watch.

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Big Molecule Watch

NOVEMBER 21, 2023

District Court for the District of New Jersey, alleging infringement of 15 patents under the BPCIA based on DRL’s submission of an aBLA for DRL_RI, a proposed biosimilar of RITUXAN (rituximab) and DRL’s provision of Notice of Commercial Marketing with respect to the same. Stay tuned to Big Molecule Watch for more updates on this litigation.

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. A recent state law failure-to-warn case in the SDNY makes that very point.

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pharmaphorum

OCTOBER 19, 2021

Biosimilar competition to AbbVie’s big-selling Humira drug in the US has just been ratcheted up by the FDA approval of Boehringer Ingelheim’s Cyltezo – which can be substituted for the reference drug without any prescriber intervention. The post FDA clears first “interchangeable” Humira biosimilar appeared first on.

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

Tobolowsky — In January 2023, Vanda Pharmaceuticals, Inc. FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). a)(8)(iv), interpret these provisions to also allow changes due to an aspect of labeling protected by patent or exclusivity. 355(j)(2)(A)(v). 355(j)(2)(A)(v).

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PharmaShots

FEBRUARY 3, 2023

4D Molecular Therapeutics Receives the US FDA’s IND Clearance of 4D-150 for the Treatment of Diabetic Macular Edema Date: Feb 03, 2023 | Tags: 4D Molecular Therapeutics, 4D-150, Diabetic Macular Edema, Regulatory, US, FDA, IND AstraZeneca and Amgen Receive the US FDA’s Approval of Tezspire (tezepelumab) for the Treatment of Severe Asthma (..)

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FDA Law Blog: Biosimilars

MARCH 29, 2023

Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. According to this announcement, FDA approval of RiVive is anticipated in July 2023 and the U.S. By Kalie E. launch would be in early 2024.

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FDA Law Blog: Biosimilars

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

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FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. So, what is special about September 24, 2023? Devices can have both a UPC code and a UDI on their label and package.

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PharmaShots

MARCH 17, 2023

5-Adapted Bivalent Booster to Treat COVID-19 in Children ≤5 Years Date: Mar 15, 2023 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5-Adapted 5-Adapted Bivalent Booster to Treat COVID-19 in Children ≤5 Years Date: Mar 15, 2023 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5-Adapted

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Big Molecule Watch

MARCH 27, 2023

On March 20, 2023, Coya Therapeutics, Inc. (“ Coya ”) announced a worldwide agreement with Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”) to license Dr. Reddy’s proposed biosimilar abatacept for the development and commercialization of COYA 302 for the treatment of neurodegenerative conditions.

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Safe Biologics

MARCH 21, 2024

On March 19th, ASBM presented to the World Health Organization International Nonpropretary Names (INN) Expert Group at the 78th Consultation on International Non-proprietary Names for Pharmaceutical Substances (INN), held in Geneva, Switzerland on October 18th, 2023. and Advisory Board Chair Philip Schneider, MS, FASHP.

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Express Pharma

JULY 17, 2024

billion in 2023 to $3.0 Another market driver is the potential label expansion of the intravenous formulation of Zolgensma to SMA patients weighing over 8.5kg and up to 21kg and the anticipated approval of an intrathecal formulation of Zolgensma for SMA type II patients aged two to 18 years. million in 2023 to $763.8

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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 ). In fact, the priority designation for the final rule is labeled as “economically significant.” According to the Unified Agenda, the proposed rule is in the final rule stage.

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European Pharmaceutical Review

DECEMBER 20, 2023

In Q1 2023, the European Commission (EC) announced proposed changes to EU pharmaceutical legislation. Changes to regulatory data protection periods are of particular interest to biopharma” Changes to regulatory data protection (RDP) periods are of particular interest to biopharma (originators and generic / biosimilar manufacturers).

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Big Molecule Watch

JUNE 29, 2023

As we previously reported , Biogen sued Sandoz and Polpharma (“Defendants”) in a BPCIA litigation related to Defendants’ natalizumab biosimilar. Oral argument was held on May 17, 2023. On June 27, 2023, the Court filed a redacted version of its order.

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Big Molecule Watch

JULY 22, 2024

In 2023, the FTC issued supplemental Orders to three additional PBM-affiliated entities. pharmacies in 2023, demonstrating this horizontal consolidation. All of the top six PBMs are vertically integrated, meaning PBMs are operating in a system that includes the drug private labeler all the way down to the pharmacy and health insurer.

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Big Molecule Watch

AUGUST 25, 2023

The statute sets a deadline of September 1, 2023 for the Secretary of Health and Human Services (HHS) to publish a list of the 10 drugs that will be subject to “negotiations” with the government to determine the “maximum fair price” for the drug under Medicare. Exceptions There are several exceptions to these general eligibility criteria.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. Notably, Part 820 will look different.

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PharmaShots

MAY 3, 2023

Our team at PharmaShots has summarized 15 key events of the biosimilar space of April 2023 1. results from the P-III clinical trial of CT-P42, a biosimilar referencing Eylea. results from the P-III clinical trial of CT-P42, a biosimilar referencing Eylea. Ximluci is supplied as a 2.3mg/0.23 mL single-use vial inj.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. of the total expenditures for all Part D drugs in 2021.

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FDA Law Blog: Biosimilars

JUNE 11, 2023

Clissold — In May 2023, CDER and CBER published a draft guidance titled “Pediatric Drug Development: Regulatory Considerations – Complying with the Pediatric Research Equity Act [“PREA”] and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act [“BPCA”]” (the “Draft Guidance”). Tobolowsky & David B.

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FDA Law Blog: Biosimilars

AUGUST 13, 2023

In the case of contract manufacturers, either the contract manufacturer or the person whose name appears on the label (i.e., FDA is developing an electronic portal for registration and listing submissions that will be available in October 2023. Comments on the draft guidance may be submitted until Sept.

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FDA Law Blog: Biosimilars

AUGUST 4, 2023

DASCA amended the CSA by revising and adding specified substances to the definition of “anabolic steroid,” providing for the temporary and permanent scheduling of anabolic steroids and adding labeling requirements for products containing anabolic steroids. Implementation of the Designer Anabolic Steroid Control Act of 2014 , 88 Fed.

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FDA Law Blog: Biosimilars

JUNE 12, 2023

The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. AAFCO also publishes model regulations, including model pet food labeling regulations which states may adopt.

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European Pharmaceutical Review

FEBRUARY 22, 2023

1 Used to treat a range of chronic diseases (eg, diabetes, rheumatoid arthritis, psoriasis, Crohn’s disease, haemophilia, etc), it is projected that the sales of biologics will rise from $380 billion in 2022 to $416 billion in 2023, and to almost $600 billion in 2027. This trial is anticipated to begin in the second half of 2023.

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FDA Law Blog: Biosimilars

APRIL 25, 2023

This provision became effective as of March 29, 2023. It will become part of the “refuse to accept” (RTA) checklist on October 1, 2023. Timeline Section 524B became effective on March 29, 2023. Until this deadline, FDA generally intends not to issue RTA decisions based solely on the information required by section 524B.

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PharmaShots

APRIL 5, 2023

neovascular (wet) AMD Additionally, the availability of Byooviz could enable more patients to access this type of vision-saving therapy as it brings a sustainable and cost-effective anti-VEGF treatment to Canadian vision care Byooviz was approved in Canada for the treatment of multiple eye disorders.

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Express Pharma

JUNE 4, 2024

The significant growth in biosimilars approvals and manufacturing further enhances patient access to biopharmaceuticals. The emphasis on biopharmaceuticals and biosimilars is increasing, driven by their rising demand. per cent in 2023, supports infrastructure development, particularly in rural areas.

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FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. In contrast , the two previous withdrawals, Makena in 2023 and Avastin in 2011, took 30 months and 11 months, respectively. On August 4, 2023, Oncopeptides submitted its appeal.

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FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

According to the latest MDUFA performance report , only 25% of 513(g)s in fiscal year 2023 met the 60-day statutory time frame. Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days.

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