Express Pharma

JUNE 28, 2024

With a focus on redefining the pharmaceutical industry in the post-COVID era, PharmaLytica 2024 offered a platform for stakeholders to engage in discussions covering the full spectrum of pharma machinery and packaging, lab analytical and cleanroom solutions, and pharmaceutical ingredients. We exported $ 27.8

Packaging 105

Packaging Biosimilars Labelling Vaccines 105

Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

Biosimilars 52

Biosimilars Packaging 52

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.

Biosimilars 40

Biosimilars Packaging Labelling 40

FDA Law Blog: Biosimilars

JANUARY 11, 2024

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

Biosimilars 59

Biosimilars Packaging 59

Express Pharma

JUNE 5, 2023

It has often been the leader in areas, such as the manufacture of generic drugs, over-the-counter medications, bulk drugs, vaccines, contract research and manufacturing, biosimilars, and biologics. Indian pharma is expected to touch the $65 billion mark by 2024.

Packaging 104

Packaging Vaccines Biosimilars 104

Big Molecule Watch

JANUARY 22, 2024

Over ABP 938 Biosimilar to EYLEA On January 10, 2024, Regeneron Pharmaceuticals, Inc. Amgen”) alleging infringement of 32 patents under the BPCIA based on Amgen’s submission of an aBLA for ABP 938, a proposed biosimilar of EYLEA (aflibercept). One patent related to packaging: S. Regeneron”) filed a Complaint in the U.S.

Biosimilars 49

Biosimilars Packaging 49

Big Molecule Watch

JANUARY 5, 2024

Regeneron seeks a PI schedule to “ensure an orderly process that will result in resolution of its forthcoming motion for PI before May 17, 2024,” when its regulatory exclusivity period ends. A status conference took place today January 5, 2024 in relation to Regeneron’s emergency motion. Patent Nos. Patent Nos. Design Patent Nos.

Packaging 49

Packaging Biosimilars Documentation 49

FDA Law Blog: Biosimilars

AUGUST 27, 2023

FDA intends the Guidance to provide “clarity and flexibility” to trading partners to “help ensure continued patient access to prescription drugs as the supply chain transitions to the interoperable, electronic product tracing at the package level under the DSCSA” while supporting “continued availability of products to patients.”

Packaging 52

Packaging 52

FDA Law Blog: Biosimilars

SEPTEMBER 24, 2024

Livornese — FDA issued a Federal Register notice on September 13, 2024, seeking feedback on the Integrated Review format that the Center for Drug Evaluation and Research (CDER) began using as part of its New Drugs Regulatory Program (NDRP) modernization effort several years ago. Comments are due by December 12, 2024. By Deborah L.

Documentation 59

Documentation Packaging 59

Pharmaceutical Technology

MAY 23, 2023

While a handful of incentives are offered by the reform package, they are overshadowed by the potential drawbacks for the innovative sector. Generic and biosimilar firms are likely to heavily utilise this provision, and earlier market entry may lead to faster price drops for branded drugs.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Biosimilars Packaging 52

FDA Law Blog: Biosimilars

MARCH 3, 2024

3558 ) on January 25, 2024. Conclusion Although the BIOSECURE Act has not been passed by Congress (or signed by the President), its sponsors are expected to push for its inclusion in the FY25 NDAA or as part of other omnibus legislative packages that arise this year. House of Representatives ( H.B. 7085 ) and Senate ( S.B.

Packaging 102

Packaging 102

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. Under § 820.45, FDA also requires manufacturers to inspect labeling and packaging for accuracy.

Labelling 59

Labelling Packaging Documentation 59

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Despite the removal of some of the most controversial proposals, the final rule still contains a variety of significant changes, which become effective on November 19, 2024. The term “drug product information” is now defined to include NDC, drug name, units per package size (UPPS), drug category (S, I, or N), unit type (e.g.,

Vaccines 59

Vaccines Inpatient Packaging Documentation 59

Safe Biologics

AUGUST 23, 2024

as in most advanced nations, a prescribing physician may substitute any biosimilar for its reference product. However, substitution of biosimilars at the pharmacy level is controversial, opposed by majorities of physicians worldwide, and banned in many countries including most of Western Europe. In the U.S. In the U.S., In the U.S.,

Biosimilars 130

Biosimilars Chemotherapy Packaging 130

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. The draft guidance recommends that no more than 15 questions are included in the briefing package. CBER will not commit to reviewing packages greater than 250 pages.

Documentation 59

Documentation Packaging Clinical Pharmacology Drug Development 59

FDA Law Blog: Biosimilars

DECEMBER 11, 2024

Karst We learned earlier this week that an allision (a runner-up to Merriam-Websters 2024 Word of the Year, polarization) may be poised to occurperhaps within a fortnight (another runner-up to Merriam-Websters 2024 Word of the Year thanks to Taylor Swift)as Congress considers various pieces of healthcare legislation as part of its year-end package.

Packaging 64

Packaging Drug Development 64