May 9th 2024
As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
European Stakeholders on Biosimilar Labeling: More Education, Clarity, and Transparency Needed
July 13th 2017To gain an understanding of how stakeholders use or consult medicinal product information and to investigate their preferences for the content of biosimilar labels, a multi-stakeholder workshop was held in Brussels, Belgium.
Patent Trial and Appeal Board Strikes Down Key Humira Patent, Again
July 12th 2017Last week, the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) ruled to invalidate AbbVie’s patent on a method of treating rheumatoid arthritis using adalimumab (Humira). The PTAB deemed the claims in question unpattentable because of their obviousness.
FDA Seeks Comments on Its Program for Enhanced Review Transparency and Communication
July 10th 2017On June 29, the Federal Register published the FDA’s request for comments concerning its statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for original 351(k) Biologics License Applications.
Biocad Expects Marketing Authorization in India for Its Rituximab Biosimilar
July 10th 2017Biocad has announced that, on June 20, India’s Central Drugs Standard Control Organization (CDSCO) recommended its rituximab biosimilar (Acellbia) for approval. The company expects to receive a permanent marketing authorization for the product in August, and anticipates that it will begin shipping the treatment to India by September.
French Inspectors Find Major Deficiencies at Biocon's Manufacturing Facility
July 10th 2017France’s health regulatory body, the French National Agency for Medicines and Health Products Safety (ANSM), found that Biocon has failed to comply with good manufacturing practice requirements for 3 of its biosimilar products manufactured at the company’s Bommasandra facility in Bangalore, India.
UK Seeks to Collaborate With EMA as Patients Fear Rising Costs, Shrinking Access
July 7th 2017The UK government sought to reassure citizens this week that “Brexit,” or the United Kingdom’s withdrawal from the European Union (EU)—and therefore its withdrawal from the European Medicines Agency (EMA)—would not negatively impact patient access to pharmaceuticals.
The STRONGER Patents Act Could Create Roadblocks for Biosimilars
July 6th 2017A bipartisan bill, introduced by US Senators Chris Coons (D-Delaware), Tom Cotton (R-Arkansas) Dick Durbin (D-Illinois), and Mazie Hirono (D-Hawaii), seeks to make a number of reforms that would make it easier for innovators—including the manufacturers of reference biologics—to defend against challenges to their patents.
Coherus Terminates 30% of Its Workforce After FDA's Complete Response Letter
July 3rd 2017Just 2 weeks after Coherus BioSciences announced that it had received a complete response letter (CRL) from the FDA in response to its biologics license application for a pegfilgrastim biosimilar candidate, the company has laid off 51 employees, or approximately 30% of its workforce, in a bid to cut its operating costs by $10 million.
Physicians Express Concerns About Biosimilar Interchangeability to FDA
June 30th 2017The 52 comments the FDA received during the public commentary period on the agency’s January 2017 draft guidance, Considerations in Demonstrating Interchangeability With a Reference Product, included statements from physicians concerned about the proposed policy.
The Supreme Court's Sandoz v Amgen Ruling Raises as Many Questions as It Resolves
June 29th 2017On June 28, Elaine Blais and Willy Jay, partners at Goodwin Proctor LLP, held a webinar discussing the Supreme Court’s Decision in the case of Sandoz v Amgen. While the court provided some much-needed clarity surrounding requirements of the Biologics Price Competition and Innovation Act “patent dance,” as Blais and Jay pointed out, the court’s ruling left a number of important questions unresolved.
An Expert Discussion: Lessons Learned and the Future of Biosimilar Uptake
June 21st 2017At the 8th Annual Summit on Biosimilars, a panel of legal experts reviewed lessons learned from the first 18 months of biosimilars in the United States, and looked ahead to the question of how these drugs will gain acceptance and market uptake.
Nevada Governor Signs Insulin Price Transparency Bill, Strictest in Nation
June 16th 2017Republican Nevada Governor Brian Sandoval yesterday signed into law the country’s strictest requirements for drug companies to show how they set prices for certain prescription drugs, with a specific focus on insulin.
Legal Experts Grapple With Implications of Sandoz v Amgen at the Summit on Biosimilars
June 15th 2017News of the landmark Supreme Court ruling in the case of Sandoz v Amgen broke during the Monday session of the 8th Annual Summit on Biosimilars, a meeting of legal and pharmaceutical industry professionals convened in New York City. In a previously scheduled—and swiftly updated—discussion of the case, a panel of attorneys grappled with the ruling and its implications for the industry.
SCOTUS Reverses Federal Circuit Court Decision in Sandoz v Amgen on 180-Day Rule
June 12th 2017In a big win for Sandoz, the US Supreme Court ruled today that a manufacturer of a biosimilar product can provide a notice of commercial marketing either before or after FDA approval of the drug to the reference product developer.
FDA Commissioner Gottlieb Focusing on Generics to Address High Drug Prices
June 7th 2017FDA Commissioner Scott Gottlieb, MD, said that the agency is examining how to push drug applications to “the front of the line” when there are fewer than 3 competing manufacturers for generic versions of a particular medication.
Demand for Greater Transparency, More Data in Demonstrating Biosimilars' Interchangeability
June 6th 2017The Biologics Prescribers Collaborative (BPC), an organization comprising 6 member groups whose memberships prescribe biologic agents, has released its comment letter to the FDA on the agency’s Considerations in Demonstrating Interchangeability With a Reference Product draft guidance, calling on the FDA to do more to “promote transparency and patient safety."