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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FDA Law Blog: Biosimilars

JANUARY 5, 2025

We described the 2022 proposed rule and the ten-plus year history leading up to its issuance in our blog post here. Turning first to the four areas in which changes were made, the focus of two of those areas were the requirements for the required labeling statements for a product approved with an ACNU. 105288 (Dec.

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Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Generic drugs and biosimilars are not eligible for this application pathway. The amendments contemplate labelling flexibilities for special containers.

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FDA Law Blog: Biosimilars

APRIL 21, 2024

But that’s the controversy here: Did FDA approve LYTGOBI NDA 214801 on September 30, 2022 when the Agency issued its initial approval letter , or on October 5, 2022 when FDA issued a corrected approval letter ? Rather, “permission for commercial marketing” was only effective upon FDA’s issuance of its corrected October 5, 2022 letter.

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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. 2022 [cited 2023Feb]. No serious adverse events were reported.

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FDA Law Blog: Biosimilars

JULY 22, 2024

s John W.M. s John W.M.

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Pharmaceutical Business Review

OCTOBER 31, 2024

In 2022, Henlius signed a licensing and supply agreement with Organon, granting the latter with exclusive commercialisation rights for two biosimilar candidates, including HLX14. This agreement applies to markets such as the US, the European Union (EU), and Canada, with the exception of China.

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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. On October 19, 2022, Biogen filed a Motion for Preliminary Injunction and Motion to Strike, while Sandoz filed a Cross Motion to Strike. Oral argument was held on May 17, 2023.

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Big Molecule Watch

JULY 22, 2024

In 2022 the FTC issued special orders pursuant to Section 6(b) of the Federal Trade Commission Act (the “6(b) Orders” or “Orders”) to the six largest PBMs—Caremark Rx, LLC; Express Scripts, Inc.; OptumRx, Inc.; Humana Pharmacy Solutions, Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc.

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Pharmaceutical Technology

JANUARY 10, 2023

Type 2 diabetes (T2D) is a crowded and competitive landscape with multiple “me-too,” generic and biosimilar drugs entering the market, with market growth primarily driven by an increasing prevalent population across nine major markets (9MM: US, France, Germany, Italy, Spain, UK, Japan, China, and India).

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FDA Law Blog: Biosimilars

MAY 8, 2023

The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA). FDA recommends manufacturers submit each modification, associated labeling changes and specific performance evaluation in the Modification Protocol (MP).

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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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FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

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. According to the latest MDUFA performance report , only 25% of 513(g)s in fiscal year 2023 met the 60-day statutory time frame.

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FDA Law Blog: Biosimilars

APRIL 25, 2023

Users of eSTAR templates need to add attachments for cybersecurity risk management, cybersecurity management plan, continuing support plan, and cybersecurity labeling. implant programming), (4) software bill of materials, and (5) general labeling (connectivity and associated general cybersecurity risks, updateability/process).

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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., The information is presented in a Q&A format. As reported previously , MOCRA includes a requirement for facility registration and listing of cosmetic products.

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FDA Law Blog: Biosimilars

AUGUST 16, 2023

The last Warning Letter OPDP issued was in early 2022 to CytoDyn for promoting its investigational drug as an effective treatment for COVID-19 despite a failed study (and despite an FDA release issued a year prior about the same failed study – but that’s another story ). Clearly, OPDP thinks differently.

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Big Molecule Watch

AUGUST 25, 2023

With the IRA, Congress changed the pricing model for certain “high-priced” Medicare-covered drugs without generic or biosimilar competition. Drugs are considered to be “qualifying single-source drugs” if they have been without generic or biosimilar competition for a certain number of years.

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FDA Law Blog: Biosimilars

JULY 6, 2023

In fact, the priority designation for the final rule is labeled as “economically significant.” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), during his remarks at the annual Food Drug and Law Institute (FDLI) conference in May 2023.

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FDA Law Blog: Biosimilars

JUNE 22, 2023

Most recently, Jeff Shuren, CDRH Director, gave a speech at the 2023 Food and Drug Law Institute (FDLI) annual conference in which he identified facilitating “availability of and access to existing and novel home-use medical technologies” as a strategic priority for 2022-2023 to advance health equity. lay users). seeking treatment).

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FDA Law Blog: Biosimilars

APRIL 30, 2023

As background, FDC Act § 505(q) states that FDA shall not delay approval of a pending ANDA, 505(b)(2) application, or 351(k) biosimilar application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. 1067, which first reared its head in Spring 2022 as an amendment to S.4348,

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FDA Law Blog: Biosimilars

MAY 19, 2023

Serial testing was defined as testing symptomatic individuals twice over three days with at least 48 hours between tests, which is in accordance with study findings from the National Institute of Health referenced here and current EUA labeling for serial testing. Customer Support Help line).

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European Pharmaceutical Review

JULY 4, 2024

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 2022 [cited 2024May]. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. researchspace.auckland.ac.nz.

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FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

Notably, this decision marks the first use of the new expedited procedures for withdrawal of an accelerated approval that were enacted in the Food and Drug Omnibus Reform Act of 2022 (FDORA). In December 2022, FDORA was enacted. Among other things, it revised the provisions relating to accelerated approval at 21 U.S.C. §

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FDA Law Blog: Biosimilars

JUNE 28, 2023

On October 18, 2022, CVM held a virtual listening session on the regulation of animal foods with certain types of claims. Furthermore, the label for the zootechnical animal food substance would need to include the statement: “Not for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animal.”

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FDA Law Blog: Biosimilars

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 For labeling documents and the 510(k) summary, FDA often requests both clean and redlined versions. Average Number of Industry Days to MDUFA IV Decision 54.69 Average Number of Total Days to MDUFA IV Decision 127.31

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FDA Law Blog: Biosimilars

JANUARY 12, 2025

Moreover, an application (NDA or BLA) based upon a surrogate or intermediate clinical endpoint seeking accelerated approval must still meet the substantial evidence of effectiveness standard and contain sufficient information to demonstrate that the drug is safe for use under the conditions of the proposed labeling.

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FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

It finalized a draft guidance published in 2022. Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.”

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Putting Patients First Blog

JANUARY 27, 2025

3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. Increased transparency will ensure that formulary practices align with broader goals of affordability and patient access.

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Pharma in Brief

JANUARY 25, 2023

Does 2022 already seem like a blur? The Pharma in Brief team is here for you with a summary of some of 2022’s most significant legal and regulatory developments in the Canadian pharmaceutical space. This left the PMPRB11 amendment, the validity of which was upheld by the FCA in December 2022 (see here ).

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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. Additonally, Rezvoglar was also approved in the US on Nov 2022 In addition to Rezvoglar, Lilly is the owner of Humulin (recombinant human insulin), Humalog (reference insulin lispro), as well as an unbranded insulin lispro product 2.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. All labeler codes that are covered by Discount Program agreements will be distributed to PDP sponsors and posted on the CMS website. had Part D expenditures on or before August 16, 2022). 1395w-114c(e).

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Express Pharma

JUNE 28, 2024

Both India and Turkey are rising in this field, presenting significant trade and cooperation opportunities In 2022, the global pharmaceutical market reached a value of $ 1.5 The significant growth in biosimilars approvals and manufacturing further enhances patient access to biopharmaceuticals. trillion, with Turkey ranking 21st.

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Safe Biologics

MAY 10, 2024

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. and Europe alike, prescribers can already substitute any biosimilar for its reference product. Currently there are 10 biosimilars that can be substituted by U.S.

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PharmaTech

JUNE 6, 2025

Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1). This covers new biotechnologically derived protein, glycoprotein, and peptide products as well as biosimilars (3, 4). Biosimilars Market Size | Industry Growth & Forecast Report. Specifications.

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FDA Law Blog: Biosimilars

MARCH 29, 2023

While many states have had standing orders that allow for the dispensing of naloxone without an individual prescription, “harm reduction programs” that provide products and services to at-risk individuals still faced logistical difficulties in acquiring naloxone due to its prescription-only status which I discussed in this October 2022 blog post.

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PharmaShots

APRIL 13, 2023

The company faced a tough time in 2019 as the first biosimilars for its best-selling drugs (Rituxan, Avastin, and Herceptin) emerged. from 2018 to 2019 Roche’s blockbuster drugs, Herceptin, Avastin, and Rituxan played significantly well against its biosimilar products. Moreover, its medical device sales faced a decline of 1.7%

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FDA Law Blog: Biosimilars

JANUARY 1, 2024

We are unable to determine whether the number of such Warning Letters issued during the entire year represents a significant increase over 2022. The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Terragene S.A.,

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