Comparative Pharmacopeia: Olanib 150 mg and Olarigen 150 mg

Product Profile: Olanib 150 mg (Everest Pharmaceuticals Ltd.)

Olanib 150 mg serves as a cornerstone in the portfolio of Everest Pharmaceuticals Ltd., specifically targeting the growing need for accessible precision oncology solutions.

Formulation and Dosage Form

Olanib is formulated as a film-coated tablet containing 150 mg of Olaparib.

• Evolution from Capsules: Early versions of Olaparib were formulated as 50 mg capsules requiring a dose of 400 mg (8 capsules) twice daily. The 150 mg tablet formulation of Olanib represents a significant advancement, reducing the pill burden to just two tablets twice daily (300 mg BID). This reduction is critical for patient adherence, as a lower pill burden is consistently associated with better compliance in chronic therapy.
• Bioavailability: The tablet formulation utilizes melt-extrusion technology to improve the solubility of Olaparib, a Class 4 drug (low solubility, low permeability) in the Biopharmaceutics Classification System (BCS). This ensures consistent absorption and therapeutic blood levels.

Packaging and Presentation

• Configuration: Olanib is typically supplied in High-Density Polyethylene (HDPE) bottles containing 120 tablets. This pack size aligns with a standard one-month supply for maintenance therapy (4 tablets/day x 30 days). Some listings also indicate smaller packs of 30 tablets, which allow for dose titration or trial periods to assess tolerability
• Identification: Patients should verify the packaging for the Everest Pharmaceuticals hologram and batch details to ensure authenticity.

Manufacturing and Quality Assurance

Everest Pharmaceuticals Ltd. manufactures Olanib at its facility in Kanchpur, Narayanganj. The company highlights its “strict adherence to cGMP” and continuous quality improvement. The plant is equipped with dedicated oncology lines to prevent cross-contamination with other pharmaceutical products. The company’s strategic move to build an API plant in the Dhaka BSCIC area indicates a commitment to controlling the quality of the raw material, a critical factor for complex molecules like Olaparib

Product Profile: Olarigen 150 mg (General Pharmaceuticals Ltd.)

Olarigen 150 mg is positioned as a premium generic option, backed by the extensive manufacturing infrastructure of General Pharmaceuticals Ltd. (GPL).

Formulation and Dosage Form

Like Olanib, Olarigen is available as a 150 mg film-coated tablet.

• Excipients: While the exact proprietary excipient mix is trade-secret, GPL’s formulations typically align with international standards to ensure stability in Bangladesh’s hot and humid climate. The film coating serves to protect the active ingredient from moisture and mask the taste of the drug, improving swallowability.
• Strength Variations: Olarigen is also available in 50 mg capsules, but the 150 mg tablet is the preferred option for maintenance therapy due to the reduced pill burden

Packaging and Presentation

Olarigen is distributed in boxes containing 120 tablets/capsules. The packaging is designed to meet regulatory standards for light and moisture protection.

• Pricing Consideration: Olarigen often commands a higher market price compared to Olanib. Online pharmacy listings suggest a price around 100,000 BDT per box though actual retail prices may vary. This premium is often attributed to the manufacturer’s brand reputation and facility certifications.

Manufacturing and Quality Assurance

GPL’s Unit 2 in Gazipur is one of the most advanced pharmaceutical facilities in Bangladesh. It is cited as complying with cGMP standards from major regulatory bodies including the UK MHRA, EU-GMP, and TGA. The facility features advanced containment technologies for oncology production.

• Regulatory Note: It is important to acknowledge that regulatory bodies in other jurisdictions, such as the FDA Philippines, have issued warnings regarding unregistered imports of Olarigen. This highlights the importance of procuring the drug through authorized domestic channels in Bangladesh where it is legally registered and monitored by the DGDA, rather than through unregulated gray markets.

Comparative Analysis: Choosing Between Olanib and Olarigen

When patients or clinicians choose between Olanib and Olarigen, several factors come into play.

Table: Side-by-Side Product Comparison

Feature	Olanib 150 mg	Olarigen 150 mg
Manufacturer	Everest Pharmaceuticals Ltd.	General Pharmaceuticals Ltd.
Manufacturing Site	Kanchpur, Narayanganj	Kaliakair, Gazipur
Dosage Form	Film-coated Tablet	Film-coated Tablet (also 50mg cap)
Standard Pack Size	120 Tablets (1 Month Supply)	120 Tablets (1 Month Supply)
Approx. Market Price	~12,000 – 48,000 BDT	~100,000 BDT
Primary Indication	Ovarian, Breast, Prostate Cancer	Ovarian, Breast, Prostate Cancer
Key Advantage	Cost-effectiveness	Facility certifications (Unit 2)

Interchangeability and Switching

From a pharmacological perspective, both products contain the same active moiety (Olaparib INN) and are regulated by the DGDA. Therefore, they should be therapeutically equivalent. However, due to potential differences in excipients, it is generally recommended that patients remain on the same brand throughout their treatment course if possible. If a switch is necessary due to cost or availability (e.g., switching from Olarigen to Olanib to manage financial burden), clinical monitoring for the first month is advisable to ensure steady-state plasma levels and consistent tolerability

Supply Chain Integrity and Storage

Given the critical nature of oncology treatment, ensuring the integrity of the medication is paramount.

Counterfeit Protection

High-value generics are targets for counterfeiting. Patients should:

• Purchase only from established hospital pharmacies or licensed distributors.
• Check for the manufacturer’s seal and holographic indicators on the box.
• Verify the batch number and manufacturing/expiry dates. Authentic products will have clear, non-smudged printing of these details

Storage Requirements

Both Olanib and Olarigen must be stored strictly below 30°C in a dry place. Exposure to high heat or humidity—common in Bangladesh—can degrade the active ingredient, rendering the drug ineffective. Patients are advised not to store the medication in bathroom cabinets or near windowsites. If home air conditioning is not available, storing the bottle in a cool, dark cupboard or a specialized medication cooler bag is recommended