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.

Biosimilars 130

Biosimilars Documentation Drug Pricing 130

Pharmaceutical Technology

OCTOBER 28, 2022

QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Practising QbD in biosimilar product development. For biosimilars, however, this process is slightly more complex.

Biosimilars 52

Biosimilars Vaccines Drug Development Documentation 52

Big Molecule Watch

APRIL 18, 2023

As we previously reported , Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023, less than a year from Regeneron’s filing of its complaint in August 2022. The post Regeneron v.

Documentation 73

Documentation Biosimilars 73

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has accepted Accord BioPharma’s Biologics Licence Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) to treat HER2 cancer types. Biosimilars are key to making healthcare more affordable and accessible. Accord BioPharma is the US specialty division of Intas Pharmaceuticals.

Biosimilars 52

Biosimilars Documentation 52

Pharmaceutical Technology

JULY 15, 2022

In a budget change proposed in February and confirmed in May , California’s Department of Health Care Access and Information (HCAI) requested a one-time investment of $100 million for Newsom’s CalRx Biosimilar Insulin initiative. The documents state that a partnership with a CMO would be cheaper than the state directly manufacturing insulin.

Biosimilars 131

Biosimilars Diabetes Documentation Packaging 131

Pharma Pathway

SEPTEMBER 22, 2022

Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Please Bring the following copies of below documents along with Originals: SSC & Intermediate Certificated & Marks Sheet. Job Role : Apprentice -Trainee.

Biosimilars 79

Biosimilars Documentation Pharmaceutical Companies Pharmaceutical Companies 79

STAT

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world. As of 2019, about 1.9 million people have type 1 diabetes in the U.S., Type 1 affects 8% of everyone with diabetes.

Diabetes 228

Diabetes Biosimilars Documentation Compounding 228

European Pharmaceutical Review

JANUARY 2, 2024

While advantages to the Quality by Design approach is clear and practical implementation of Quality by Design is encouraged by publication of public guidance documents ICH Q8(R2) – ICH Q14, the industry has not yet fully embraced the QbD approach in Marketing Authorisation Applications (MAAs) for European market approval, the authors noted.

Drug Development 95

Drug Development Biosimilars Documentation 95

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. For example: Reduced stay. Revised section 8 damages.

Biosimilars 52

Biosimilars Dosage Documentation 52

Pharma in Brief

SEPTEMBER 8, 2022

This case concerns biosimilar presentations of an AbbVie Corporation and AbbVie Biotechnology Ltd. JAMP filed a new drug submission ( NDS ) for its biosimilar adalimumab product, SIMLANDI, in three presentations: (i) a 40 mg/0.4 Guidance Document : Information and Submission Requirements for Biosimilar Biologic Drugs.

Biosimilars 52

Biosimilars Dosage Documentation 52

European Pharmaceutical Review

DECEMBER 20, 2023

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). What are the latest amendments?

Biosimilars 83

Biosimilars Labelling Documentation 83

FDA Law Blog: Biosimilars

AUGUST 16, 2023

Document dumps,” he said, are not helpful without the assistance of a narrative placing the documents in context.

Documentation 97

Documentation 97

FDA Law Blog: Biosimilars

MAY 6, 2024

The guidance does not define “on a reasonably justified regular cycle” or “as soon as possible” but instead recommends manufacturers should “update appropriate cybersecurity documentation (e.g., Appendix 4) for the documentation requirements to “demonstrate reasonable assurance that the device and related systems are cybersecure”.

Documentation 105

Documentation 105

FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

Compared with the COVID-centered version of the document released in April 2021, there is very little that is new or different. RIEs will require the facility to accommodate the “use of teleconference, livestream video, and screen sharing of data and documents.” We should explain what RIEs are.

Documentation 105

Documentation Medical Records 105

pharmaphorum

APRIL 16, 2021

NICE noted in its guidance document that “patient experts explained that the fortnightly infusions make it difficult for people to work, socialise and join in with family life.” Ultomiris is Alexion’s follow-up to its rare diseases blockbuster Soliris (eculizumab), which allows for an eight-week dosing schedule after a loading phase.

Biosimilars 52

Biosimilars Documentation 52

FDA Law Blog: Biosimilars

JUNE 27, 2023

FDA also requests a “detailed description of the allegation with any available supporting documentation.” In our experience, the more detailed the documentation that accompanies the submission, the more likely FDA will follow-up on the submission.

Documentation 59

Documentation Labelling Communication 59

FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

Her expertise includes preparation and maintenance of licensing documentation, communications with state boards and government agencies, conducting research, and the preparation of associated licensing documentation and applications.

Controlled Substances 45

Controlled Substances Documentation Pharmaceutical Manufacturing Communication 45

FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M.

Documentation 105

Documentation 105

FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

Documentation 64

Documentation 64

Drug Channels

OCTOBER 11, 2022

Drug Distribution Industry Expands as COVID-19 Disruption Fades and Biosimilars Boom (press release) We’re offering special discounted pricing if you order before October 21, 2022! We also update sections that were introduced in recent editions, such as our estimates of wholesalers' profits from provider-administered biosimilar drugs.

Biosimilars 56

Biosimilars Hospitals Pharmaceutical Manufacturing Documentation 56

FDA Law Blog: Biosimilars

JUNE 28, 2023

As part of that effort, Accreditation Scheme for Conformity Assessment (ASCA) is designed to reduce FDA review time, reduce and/or remove Sponsor guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted.

Documentation 52

Documentation 52

Pharmaceutical Technology

FEBRUARY 24, 2023

But the EU draft document says that the changes will make medicines more affordable, improve unequal access to medicines across the EU, and fulfil unmet patient needs. He pointed out that Europe was the first region to approve biosimilars. You can compare timelines.

Biosimilars 64

Biosimilars Documentation 64

FDA Law Blog: Biosimilars

APRIL 19, 2023

The new draft guidance continues to borrow heavily from the NDA process and FDA notes that it used the same source material on which other drug application recommendations are based including the Common Technical Document (CTD). x 11-inch paper, and with hyperlinks to references and numbered pages.

Documentation 59

Documentation Labelling 59

FDA Law Blog: Biosimilars

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Through a recent (and very short) Guidance document, FDA indicated that, starting on October 1, 2023, FDA may base “refuse to accept” (RTA) decisions on the information required by section 524B.

Documentation 105

Documentation Labelling Communication 105

Drug Channels

OCTOBER 5, 2021

Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: Biosimilars Are Delivering Higher Profits for Drug Distributors (press release) We’re offering special discounted pricing if you order before October 15, 2021! Section 4.4.

Biosimilars 62

Biosimilars Pharmaceutical Manufacturing Hospitals Documentation 62

FDA Law Blog: Biosimilars

AUGUST 9, 2023

As with other required controlled substance records, electronic records documenting EPCS transfers must be maintained for two years from the transfer date by both the transferring and receiving pharmacies. to be codified at 21 C.F.R. to be codified at 21 C.F.R.

Controlled Substances 52

Controlled Substances Documentation Communication 52

FDA Law Blog: Biosimilars

OCTOBER 16, 2023

Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year.

Documentation 119

Documentation 119

Drug Channels

OCTOBER 10, 2023

Drug Distribution Industry Gaining from Anti-Obesity Drugs and Provider-Administered Biosimilars (press release) We’re offering special discounted pricing if you order before October 20, 2023! There are loads of internal hyperlinks to help you navigate the document and customize it to your specific interests and priorities.

Specialty Pharmacies 40

Specialty Pharmacies Biosimilars Pharmaceutical Manufacturing Documentation 40

FDA Law Blog: Biosimilars

JUNE 20, 2023

The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry. Like other guidance documents that preceded it, the draft guidance will be open to the public for comment. Once final, the guidance will be implemented and review staff will be trained.

Documentation 45

Documentation Communication 45

pharmaphorum

SEPTEMBER 16, 2021

Promoting automatic substitution of, for example, biosimilars on formularies and registers could accelerate conversion to use of biosimilars, releasing significant financial savings. But in some areas of prescribing national leadership is needed to accelerate and support local systems’ medicines optimisation efforts.

Biosimilars 113

Biosimilars Community Pharmacies Medical Records Documentation 113

Big Molecule Watch

JANUARY 5, 2024

The proposed schedule also provides dates for document discovery and depositions. District Court for the Northern District of West Virginia, alleging infringement of 51 patents under the BPCIA based on Samsung’s submission of an aBLA for SB15, a proposed biosimilar of EYLEA (aflibercept).

Packaging 62

Packaging Biosimilars Documentation 62

FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

In brief, in regard to proof of identity, the seller must obtain sufficient information to identify and document the identity of the purchaser. Thus, such persons are subject to identification, recordkeeping, and reporting requirements. 1310.06.

Controlled Substances 116

Controlled Substances Documentation 116

FDA Law Blog: Biosimilars

MAY 13, 2024

This guidance, when finalized, will replace the original version of this document finalized in 2017. Of course, as FDA has itself acknowledged, RWE can offer some significant compensatory advantages.

Medical Records 110

Medical Records Documentation 110

FDA Law Blog: Biosimilars

JUNE 8, 2023

It is also crucial to maintain a respectful and cooperative demeanor, document the meeting discussion and action items, and promptly address follow-up actions. FDA notes that all in-person FTF formal meetings at CDER and CBER will have a hybrid component (virtual attendees in addition to in-person attendees).

Communication 53

Communication Biosimilars Documentation 53

FDA Law Blog: Biosimilars

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

Documentation 108

Documentation Vaccines Drug Development 108

Pharmaceutical Technology

SEPTEMBER 15, 2022

Upcoming biosimilar competition for Humira means AbbVie’s focus may turn to Rinvoq, approved in the US for atopic dermatitis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis, and Skyrizi, approved in the US for psoriatic arthritis and plaque psoriasis. Bristol Myers Squibb (BMS) documented a 9.1%

Vaccines 108

Vaccines Drug Pricing Biosimilars Documentation 108

FDA Law Blog: Biosimilars

JULY 10, 2023

In this case, the FDA clock start date is determined as the date of receiving the submission by the Document Control Center (DCC). When referencing documents within the AI response, cite location within the 510(k) supplement (e.g., Attachment number) and document name or description as appropriate.

Documentation 75

Documentation Packaging Communication Labelling 75