GaBI online

Tentative FDA approval for chemotherapy generic

Aurobindo Pharma (Aurobindo) has received tentative US Food and Drug Administration (FDA) approval for chemotherapy generic palonosetron. The Indian generics maker received tentative FDA approval for its generic injectable intravenous palonosetron at a dosage of 0.25 mg/5 mL on 4 November 2015. The originator product Aloxi/Onicit/Paloxi (palonosetron) is manufactured by Helsinn Birex Pharmaceuticals and was approved by FDA on 25 …

Thomson reuters report

Thomson Reuters press-release: World Generic Medicines Congress Europe

The World Generic Medicines Congress Europe organized by Health Network Communications brought together industry stakeholders, decision makers, and experts for two days of presentations and discussions focused on market challenges and portfolio strategy. The industry has seen a collapse of traditional commodity generic models, while a new model is emerging from innovation and consolidation, supported by strategic geographic expansion. The …

India government launches its own brand to sell cheap generic drugs

India is well known to be one of the “workhorse” in generic production. Despite the comparable reasonably priced drugs in global market, the lower income population is still having difficulty in affording them during treatments. As an initiative to provide more holistic healthcare services for all, Indian government has decided to step in and control generic prices by purchasing and …

Eatern Europe, CIS, Generics

Back to the future

At the World Generic Medicines Congress Europe 2014, Stephen Stead, Ranbaxy, gave the presentation: “Back to the future” discussing the pharma industry. Download and learn: Volatility Diversity Russia Pharma market size and its dynamic Split of Innovator & Generics CAR Countries Ukrainian Pharma Environment Main market segments dynamics Cost containment and Volatility not Sustainability Download presentation  Found this interesting? Join us at …

biosimilar, biosimilar drug development, biosimilar perspectives, industry, intelligence

Download ebook: Biosimilar Industry Intelligence – 5 Key Perspectives

Change in the biosimilars industry is really picking up pace. The regulatory environment is becoming ever more stable and organisations are continuing to explore development, clinical and commercial strategies that offer genuine value to them, healthcare providers and most importantly, the patient. It is a busy time for the industry, but it is important to know the latest regulatory and industry developments, realise the …

Hikma, Pharma, Generics

Review of market dynamics in MENA: What are the market drivers, opportunities and challenges?

At the World Generic Medicines Congress Europe 2014, Salah Mawajdeh, Hikma Pharmaceuticals, gave a presentation on “Review of market dynamics in MENA: What are the market drivers, opportunities and challenges?”  The presentation focuses on healthcare and growth within the MENA region. Download and learn: The pharmaceutical industry in MENA High barriers to entry in the MENA & Hikma’s differentiated market position …

Generics in Asia

Lower labor cost, relatively well-trained workforce and encouraging government policies are among the factors which promote the transition of Asia into manufacturing hub for bio- and pharmaceutical products. With the expiry of patented drugs, generic manufacturers see the opportunity in competing with the previous monopolies in hope to earn a share in this lucrative market. How do new generics companies …

Generic, Industry,

Where is the Generic Industry Heading?

At the World Generic Medicines Congress Europe 2014, Dr Gyorgy Thaler, Director of Development, Gedeon Richter gave a presentation entitled “Where is the (Generic) Industry Heading?” The presentation expresses Thaler’s belief that the generic industry needs to re-invent itself , a new message needs to be created: What do we bring to the patients? Why do they need us? How can …

Cadila’s biosimilar at 20% of Humira price

You heard it right, the new biosimilar of adalimumab (brand name: Humira by Abbvie) was launched by Zydus Cadila with the name of Exemptia in India. This is the first biosimilar of adalimumab which is currently priced at one-fifth of Humira’s. (Read full article here) Biosimilars are significant biopharmaceutical products in  many countries in Asia. These biological products are similar, or  highly …

IP, Pharma, Generics, Opportunities, Challenges, Europe,

IP in Pharma Generics Opportunities & Challenges in the EU

At the World Generic Medicines Congress Europe 2014, Thomas Kolzau, Helm AG, gave a presentation entitled “IP in Pharma Generics Opportunities & Challenges in the EU” Download and learn: Opportunities – pharma generics Challenges – pharma generics Oppositions in the generic market Appeals in the generic market Settlement Manufacturing & stockpiling Importance of the EU generics industry Impact of a manufacturing …