Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. regarding its administration, preparation, storage, or safety).

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FDA Law Blog: Biosimilars

MAY 13, 2024

Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market.”

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Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Eight products received recommendations for conditional marketing authorization and one product was reviewed “under exceptional circumstances.” Reviews of orphan medicines and biosimilars have remained stable over the past three years.

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The Pharma Data

NOVEMBER 10, 2020

On October 31, 2018 , Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of cancer, metabolic, autoimmune and other major diseases.

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The Pharma Data

APRIL 6, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Organon Finance 1 LLC plans to offer, subject to market conditions, euro-denominated senior secured notes due 2028, U.S. dollar-denominated senior secured notes due 2028 and U.S.

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The Pharma Data

JANUARY 20, 2021

Much of the new recruitment has taken place at their new clinical and commercial manufacturing site in Warsaw, which began construction in 2018. Polpharma Biologics is a European biopharmaceutical company focused on the development and manufacture of biosimilar and novel biologic drugs. About Polpharma Biologics.

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The Pharma Data

APRIL 8, 2021

This announcement is an advertisement and is not a prospectus for the purposes of Regulation (EU) 2017/1129 (as amended, the “Prospectus Regulation”) or Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 (the “UK Prospectus Regulation”).

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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.

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FDA Law Blog: Biosimilars

JUNE 16, 2023

In other words, a violative manufacturer not only pays penalties, but is also compelled to continue marketing the drug in Minnesota (at a reduced price). For now, we will continue to monitor the law, its future implementing regulations, and any legal challenges as they develop.

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The Pharma Data

DECEMBER 13, 2020

About Toripalimab Toripalimab is the first domestic anti-PD-1 monoclonal antibody to obtain marketing approval in China. On December17 ,2018, Toripalimab obtained conditional approval from the NMPA, for the 2 nd line treatment of patients with unresectable or metastatic melanoma.

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The Pharma Data

JANUARY 24, 2021

About Toripalimab Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma.

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The Pharma Data

MAY 15, 2023

Before joining EMMI Group as CEO, he was a Member of the Executive Board and Head of the Marketing Department at Migros-Genossenschafts-Bund. He holds a Master degree in Marketing and Trade from the University of St. Before joining Lufthansa, he served as Group CFO at Barry Callebaut based in Switzerland from 2018 through 2020.

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Agency IQ

OCTOBER 6, 2023

This is a significant jump from any previous year, with the former peak at 15 in FY 2018, followed by several years in the 10-14 range. Amanda Conti, AgencyIQ What kind of biologic products entered the market? As AgencyIQ has previously discussed , developing biosimilars is an expensive process. Read the AgencyIQ analysis here.

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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 If the response to an AI request does not successfully address all deficiencies, FDA will issue an order declaring a device not substantially equivalent (NSE) to a legally marketed predicate device (NSE letter).

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The Pharma Data

DECEMBER 27, 2020

Following changes to our leadership team in late 2018 and early 2019, we have sought to transform Lineage into the preeminent allogeneic cell transplant company. Finally, we seek to generate compelling clinical data to support moving into late-stage clinical trials and eventual marketing authorizations.

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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. FDA also directed manufacturers to produce detailed marketing plans.

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FDA Law Blog: Biosimilars

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] 11] In fact, in Fiscal Years 2018 – 2022, fewer than 100 510(k)s went through the Third-Party Review Program annually. [12] of 510(k) decisions, respectively. [13]

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The Pharma Data

NOVEMBER 9, 2020

2018 for patients with severe asthma, without an eosinophilic phenotype. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future.

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The Pharma Data

JULY 15, 2021

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

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The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.

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The Pharma Data

AUGUST 1, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $674 Million; Global Rinvoq Net Revenues Were $378 Million – Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.816 Billion, an Increase of 14.1 percent on an operational basis, due to biosimilar competition.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

. § 156 and interpretive case law, if an applicant for patent term extension has multiple NDA approvals of a product, PTE applicant can only rely on ‘a’ (single) regulatory review period for a first permitted commercial marketing or use of a product to establish the requirements for patent term extension. 2018) , Arnold Partnership v.

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The Pharma Data

JULY 8, 2021

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

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The Pharma Data

APRIL 7, 2023

In 2018, the FDA approved BRAFTOVI + MEKTOVI in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Inappropriate activation of this pathway has been shown to occur in many cancers, including melanoma, CRC, and NSCLC.

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The Pharma Data

FEBRUARY 8, 2021

to €115 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. 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. Plavix ® sales were down 1.4%

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The Pharma Data

FEBRUARY 4, 2021

to €115 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. 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. Plavix ® sales were down 1.4%

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The Pharma Data

APRIL 27, 2021

and strong uptake in global markets, including China. to €137 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. In Europe, generic competition has started in certain countries after the expiration of Jevtana ® ’s market exclusivity in March 2021. In the U.S.,

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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 Recorded a $4.7

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The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. and four additional selling days in international markets. This guidance may be adjusted in the future as additional contracts are executed.

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The Pharma Data

APRIL 11, 2021

Patients must have relapsed after the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody (e.g., NHL is the most common hematologic malignancy and the tenth most common cancer worldwide, with about 510,000 new cases diagnosed in 2018. It accounts for about 250,000 deaths per year worldwide.

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