Generic Drugs

Growth is expected for the generic drugs and biosimilars sectors, driven by cost pressures on healthcare systems.

Frustrated with chronic shortages and high costs, hospitals form their own generic drug company.

The US Government Accountability Office released a report stating that FDA should make its plans to release guidance regarding nonbiological complex drugs public.

The agency published draft guidance on good practices for submitting abbreviated new drug applications.

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.

In the wake of generic-drug pricing pressure and declining revenues, Teva has restructured its commercial business and made executive leadership changes.

Ontruzant is the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved in Europe.

The debate continues over biosimilar naming, interchangeability, and patent protection, as well as lingering concerns in the medical community about the safety of switching patients to new therapies.

Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.

Merck KGaA completes the divestment of its biosimilars business as part of its strategy to focus on developing a pipeline of innovator drugs.

The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.

Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.

FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 

FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.

The agency has published a Q&A guidance document related to self-identification of facilities, review of generic drug submissions, and inspections.

The company has entered into a settlement agreement with generic-drug companies to resolve patent litigation.

A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.

The agency announced it is taking steps to increase competition within the prescription drug market.

The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.

FDA Commissioner Scott Gottlieb announced the agency will hold a public meeting on drug competition as part of its Drug Competition Action Plan.

The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.

The agency released several new and revised guidance documents regarding product-specific generic drug development.

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.

EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.

Forecasts were lowered, Reuters reported, due to reduced drug approvals and increased competitive pressures.

Sandoz, a Novartis division, announced  that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending the approval of its biosimilars rituximab and  etanercept in Europe, for the same indications as the respective reference medicines.

Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.

Will new generic drugs bring the cost of medicines down in the way policy makers hope?

In 2016, FDA approved 630 ANDAs and tentatively approved 183 ANDAs, the highest number to date, according to the report.